Dear New World Investor:
Cyclical bull and bear markets can last from several months to a few years. Secular bulls & bears last several years to decades and include multiple cyclical markets. The 2022 cyclical bear was far closer to the average cyclical bear in a secular bull than a cyclical bear in a secular bear.

I continue to think we are in a secular bull market to 2036, based on the 36-year cycle that last peaked in 2000. But there will be cyclical bear markets along the way. Bear markets usually start when everyone is bullish – not because they are bullish, but because events and factors that might be shrugged off in a doom-and-gloom environment can derail those who are overleveraged in a snorting bull market.
So I am keeping an eye on this: Retail traders haven’t been this bullish on US stocks in 27 months, the last time the market was notching all-time highs. The American Association of Individual Investors sentiment survey hit a 12-month high for bulls this week:
Click for larger graphic h/t AAII
The closely watched bull-bear spread was positive for the seventh straight week, rising to 29.9 in the week ending July 19. That’s the most bullish stance since April 2021, and a jump from a 15.1 reading in the prior period.
Data compiled by Vanda Securities shows the day trader crowd – often over-leveraged – has piled into big tech and benchmark exchange-traded funds in recent weeks, including pushing more than $7.2 billion into the equity market over the past five sessions. I’m a long way from bearish, but that certainly makes me less bullish in the short-term.
It’s important to remember that after a bear market makes everybody feel terrible, the subsequent bull markets can last for years.
Market Outlook
The S&P 500 added 0.6% since last Thursday, including a new 52-week high yesterday, and is up 18.1% year-to-date. The S&P has gone 38 days without a 1% decline – last seen at the November 2021 top. Many similar streaks ended with some big volatility spikes. Watch closely for the first 1% down day – it could mark another important turn in stocks.

Longer term, the very experienced Ed Yardeni wrote: “We see the bull market that started on October 12, 2022, continuing through at least the end of next year with the S&P 500 reaching a new record high somewhere between 4,800 and 5,400 over the next 18 months.” He expects S&P 500 earnings to hit $270 per share by 2025, about the same as the Wall Street’s consensus for $275. He thinks the Index will trade between 17.8x and 20x forward earnings by the end of 2024.
The Nasdaq Composite lost 0.5% but still is up 34.4% for the year. The small-cap Russell 2000 added 0.8% and is up 11.7% in 2023.
Even after today’s move up to 13.99, the CBOE Volatility Index (VIX) under 14 has never been an important peak the first couple of times tagging it. It takes many months to years of complacency before peaks hit. The bull market is young.
The fractal dimension shows the current uptrend still has some energy to go higher, but we’re getting close to the end. Perhaps an earnings season that’s not as bad as expected will provide the last bit of juice.
Top 5
Changes this week: None
Near-Term – chronological order
EQT EQT –natural gas price rebound
USL United States 12 Month Oil Fund, LP – crude should rise quickly
FCX Freeport McMoRan – copper shortage this fall
SFTBY SoftBank – for ARM IPO this fall
AKBA Akebia – Vadadustat NDA filing 2023; approval 2024
VLD Velo3D – Rapid revenue growth; low market cap
Long-Term – alphabetical order
EQT EQT – largest US natural gas company
NVTA Invitae – the winner-take-most of genetic testing
META Meta – a (the?) leader in the metaverse
RKLB Rocket Lab – #2 to SpaceX in space
VLD Velo3D – Return manufacturing to the US
GBTC Grayscale Bitcoin Trust – Bitcoin is headed for $100,000
Economy
Business Insider had an interesting article on a list complied by UBS economists: 10 reasons why the recession that Wall Street predicted to death never showed up. It’s well worth a read, especially if you disagree with any of these points.
1. Monetary policy isn’t all that tight yet
2. Government spending is back on the rise
3. Strong savings are fueling consumption
4. Debt levels aren’t too high
5. Credit conditions haven’t tightened much
6. Labor market remains robust
7. Economic data trends are stabilizing
8. Sectoral downturns
9. Services growth remains solid
10. The economy is less cyclical now
Dollar Death Watch
Earnings outside the US are picking up, but whether this is organic growth or the product of a falling dollar is unclear, because the MSCI earnings estimates are all quoted in dollars. With the DXY decisively breaking through support, it likely is a factor to some degree.
A weaker dollar usually is good for the prices of stocks and commodities, especially precious metals.
Coming Events
All times below are ET, and most presentations and slides are archived on the companies’ websites so you can listen to them.
Monday, July 24
AG – First Majestic – Through 7/27 – The Rule Symposium
Tuesday, July 25
GLW – Corning – 8:30am – Earnings conference call
Short Interest – After the close
EQT – EQT – After the close – Earnings release; call tomorrow
AKBA – Akebia – 4:30pm – H.C. Wainwright Kidney Conference fireside chat
Wednesday, July 26
EQT – EQT – 10:00am – Earnings conference call
Fed Meeting statement – 2:00pm
META – Meta Platforms – 5:00pm – Earnings conference call
ENVX – Enovix – 5:00pm – Earnings conference call
Friday, July 28
Personal Consumption Expenditures Index – 8:30am
Big Tech: The Biotech & Digital Dominators MegaShift
There are at least four ways to make money in the stocks of these large, growing, dominant companies. You can:
* * Buy a stock and hold it
* * Buy a stock and write a call option against it
* * With a Level IV options account, write an out-of-the-money put option
* * With a Level IV options account, write an out-of-the-money put option and use part of the premium to buy an out-of-the-money call option
Apple (AAPL – $193.13) spiked to an all-time high, gaining $60 billion in market capitalization in seconds on a Bloomberg report it is working on its own ChatGPT tool – just like everyone else. Or is it? Sure, it would compete with Google’s Bard, Microsoft’s Bing, and ChatGPT. But the difference is that Apple has 1.5 billion active iPhones out there, so they must be looking at an easy-to-use, probably embedded, consumer application.
Siri is the obvious beneficiary but Apple undoubtedly will support developers to use a Large Language Model to build iOS, watchOS, tvOS, and macOS applications. Once those are ready, they’ll introduce the AI apps to customers. Tim Cook takes no prisoners.
Click for larger graphic h/t @svpino
Morgan Stanley reiterated their Overweight rating and raised their 12-month target price from $190 to $220. Based on data from their latest new AlphaWise India Smartphone Survey of more than 3,000 urban smartphone owners, they estimate that India can add over 170 million new Apple users. The analysts say revenue from India can grow at a compounded annual rate of more than 20% to reach nearly $40 billion over the next 10 years.
Apple got a record 54 Emmy Award nominations Ted Lasso was the most Emmy-nominated comedy for the third consecutive year, and STILL: A Michael J. Fox Movie was this year’s most nominated documentary film or docuseries. AAPL is a Buy under $150 for new iPhone rollouts and augmented/virtual reality products.
Corning (GLW – $33.18) reports June quarter results next Tuesday morning. Analysts are expecting revenues to fall 7.4% from last year to $3.48 billion, with earnings down 19.3% from 57¢ to 46¢. That’s a pretty low bar,
The company announced Viridian Vials, a pharmaceutical glass-packaging technology that can improve filling-line efficiency by up to 50%. GLW is a Buy under $33 for the 5G cellular buildout, followed by the smartphone upgrade to use 5G services. My target is $60 in 2024 .
Gilead Sciences (GILD – $79.94) got FDA approval for Veklury (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. Veklury is the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease. It was approved in June for the same indication in the European Union. GILD is a Long-Term Buy under $80 for a first target of $120.
Meta Platforms (META – $302.52) reports June quarter results next Wednesday after the close. The consensus is looking for revenues up 8.0% to $31.12 bullion as Meta continues to struggle with Apple’s privacy changes. Earnings per share should be up 18.3%, from $2.46 to $2.91.
An unidentified options trader bet $40 million on further gains in Meta’s share price by buying over 26,000 call options to purchase Meta shares at $320 apiece by January 17, 2025. Bonne chance! META is a Buy under $150 for a $400 target in 2024.
Small Tech
Enovix (ENVX – $21.07) reports June quarter results next Wednesday at 5:00pm EDT. Wall Street expects a 22¢ loss per share.
The company announced general availability of its standard-sized IoT (Internet of Things) and Wearable batteries, with double the capacity of current products. Most of the revenue in this area will come from custom sized batteries, but there are products that use a standard size. ENVX is a Buy up to $13 for a 4-year hold to $100+ as their BrakeFlow lithium-ion battery takes market share.
Rocket Lab USA (RKLB – $7.81) successfully launched seven satellites for NASA Space Flight Laboratory and Spire Global, including a splashdown and ocean recovery of the first booster stage. It was Rocket Lab’s seventh launch this year and 39th Electron launch overall. RKLB is a Buy up to $13 for my $30+ target as low earth orbit satellites and space exploration grow.
Primary Risk: A new competitor emerges.
Biotech MegaShift: The $20-For-$1 Stocks
Say you put $2,000 into a stock that goes from 50¢ a share to $10. The $2,000 turns into $40,000. Then you put the $40,000 into another stock that goes from 50¢ to $10. That turns the $40,000 into $800,000. You did it with two stocks and never risked going negative more than $2,000. (Not that you won’t be mad at me if the first one works and then the second one doesn’t, taking your $40,000 to Money Heaven.)
If you can afford it – and it would not be too big a position in your portfolio – putting $2,000 into each of these speculative biotechs might be a good way to start. Buying these out-of-favor, fallen, or forgotten companies that can get important products through the FDA at very low market capitalizations seems like a good strategy to me.
Risks
Development-stage biotechs are subject to investor sentiment swings from wildly optimistic to excessively pessimistic – mostly the latter recently. After the Primary Risk for each company, I’ve added the clinical stage of their lead product, the probable time of their first FDA approval, and the probable time of their next financing.
As always, you need to think about an appropriate position size. You could buy a full position upfront and then just hold on, or buy some upfront and leave room to add more on the inevitable financings, transient clinical trial setbacks, and the like.
Akebia Therapeutics (AKBA- $1.23) completed their End of Dispute Type A meeting with the FDA. They expect to receive the FDA’s meeting minutes by mid-August and plan to resubmit their New Drug Application for vadadustat by the end of the September quarter. Upon acceptance, they expect the FDA to set a PDUFA date of six months from the date of submission. Buy AKBA up to $2 for the vadadustat lunches in the EU, UK, and (after FDA approval in 2024) the US.
Primary Risk: Vadadustat not approved in the US.
Clinical stage of lead product: Vadadustat NDA to be refiled
Probable time of next FDA approval: Mid-2024
Probable time of next financing: Unknown
Compass Pathways (CMPS – $8.96) published their Phase 2 trial results of COMP360 in the peer reviewed Nature journal, Neuropsychopharmacology>. CMPS is a Buy under $20 for a very long-term hold to a 10x.
Primary Risk: Their drugs fail in the clinic.
Clinical stage of lead product: Phase 2
Probable time of first FDA approval: 2025
Probable time of next financing: Late 2023
Graphite Bio (GRPH – $2.76) held their annual meeting and did NOT say anything about their next direction. It was a missed opportunity. According to the 10-K, their pipeline looked like this:
With nula-cel (GPH101) dead, because most of their other programs use the same gene editing platform technology as nula-cel, they have stopped development of GPH102, GPH201, GPH301, and therapeutic protein production. That leaves only non-genotoxic conditioning (NGTC) with undisclosed targets, a very early stage program. I have reached out to the company for further clarification.
GRPH is a Hold until the conference call.
Primary Risk: Their drugs fail in the clinic.
Clinical stage of lead product: Pre-clinical
Probable time of first FDA approval: Unknown
Probable time of next financing: Unknown
ScyNexis (SCYX – $2.97) said China’s National Medical Products Administration (NMPA) accepted a New Drug Application for ibrexafungerp tablets for the treatment of vulvovaginal candidiasis in the Chinese mainland. The application was submitted by their partner, Hansoh Pharmaceutical. Buy SCYX under $2.50 for a first target price of $20 after ibrexafungerp is approved for hospital use and a buyout at $50.
Primary Risk: Ibrexafungerp fails to sell.
Clinical stage of lead product: Approved
Probable time of next FDA approval: 2023/2024
Probable time of next financing: Never
TG Therapeutics‘ (TGTX – $20.95) Briumvi (ublituximab) is a much better drug than Roche’s Ocrevus (ocrelizumab) because it has a far better binding affinity, which means much lower drug is needed and therefore much lower side effects.

I still expect a buyout and I’m raising the likely price to $30 or more. Hold TGTX for a target price in a buyout of $30 or more now that the MS drug is approved.
Primary Risk:Briumvi, the MS drug, fails to sell.
Clinical stage of lead product: Approved
Probable time of next FDA approval: NM
Probable time of next financing: Second half of 2023
Inflation MegaShift
Gold ($1972.10) went over its 50-day moving average this week and is up about 15% year-over-year, with silver up over 30%.
The fractal dimension is flattening a little, but basically says says there’s more upside left in this move. However, it will flip into consolidation quickly if the uptrend stalls here.
Miners & Related
First Majestic (AG – $6.81) said June quarter production reached 6.3 million silver equivalent ounces, consisting of 2.6 million silver ounces and 45,022 gold ounces. In the first half of 2023, they produced 5.2 million silver ounces and 105,616 gold ounces, or approximately 14.0 million silver equivalent ounces.
In the second half of 2023, they expect to produce between 5.3 to 5.9 million silver ounces and 86,000 to 95,000 gold ounces, or approximately 12.4 to 13.8 million silver equivalent ounces, at an all-in sustaining cost range of $17.69 to $18.92 per silver equivalent ounce.
They had up to 19 drill rigs active during the quarter and drilled 42,285 meters, a 15% increase from the March quarter. They had high-grade exploration results at San Dimas, Santa Elena, and Jerritt Canyon. AG is a Buy under $11 for a $23 next target price as production increases and the price of silver rises.
Primary Risk: Prices of precious metals fall due to US dollar strength.
Sandstorm Gold (SAND – $5.45) did an unscripted 23-minute video interview with CEO Nolan Watson answering some of shareholders’ most asked questions.
SAND is a Buy under $10 for a $25 target.
Primary Risk: Prices of precious metals fall due to US dollar strength.
Cryptocurrencies
Cryptocurrencies are a diversifying asset that offer a unique opportunity to make (or lose!) a lot of money quickly. You can easily buy bitcoin and other cryptocurrencies at Coinbase, Block, or Robinhood.
Bitcoin (BTC-USD on Yahoo – $29,718.27) slipped below $30,000 as the US government sold $301 million of the bitcoin they seized from Silk Road. In March they briefly depressed prices by selling 9,861 coins for $216 million.
The SEC accepted a second spot Bitcoin ETF application for review in the space of a week. On Monday, they added Valkyrie’s proposal to launch the Valkyrie Bitcoin Fund to its official docket. There’s not a chance they’ll approve it, though, until the courts force them to.
BTC-USD, ETH-USD, GBTC, and ETHE are Strong Buys.
Primary Risk: Bitcoin falls due to over-regulation or is surpassed by another cryptocurrency.
Grayscale Bitcoin Trust (GBTC- $19.59) remains a Strong Buy under net asset value.
Primary Risk: Bitcoin falls due to over-regulation or is surpassed by another cryptocurrency.
Commodities
Oil – $75.63
Oil seems anchored to $75, doing what it should: consolidating after a big move higher and waiting for additional physical tightness. Crude draws in the US will get bigger as Gulf Coast temperatures drop and refiners run without hiccups. The next 10 to 12 weeks will see substantial inventory drains and prices rising. The setup for the second half of 2023 remains extraordinary, led by demand for gasoline and jet fuel.

The Energy Information Administration said shale oil production, which hit record highs in June and July, will stop growing in August. US crude production is set to fall in August for the first time this year to 9.4 million barrels a day, led by a drop in the oil-rich Permian Basin. Combined with production cuts from the OPEC+ alliance, the US decline is expected to tip the world’s oil supply into deficit by the end of the year. The Russians and Saudis are following through with their production cuts, and the Saudis just extended the extra 500,000 barrels a month cut through the end of 2024.

The July 2026 Crude Oil Futures (CLN26.NYM – $66.00) are a Buy under $65 for a $200+ target. Only buy futures for all cash; do not use margin.
The United States 12 Month Oil Fund, LP (USL – $34.83) is a Buy under $35 for a $100+ target.
EQT (EQT – $40.82) reports June quarter results after the close next Tuesday, with the conference call Wednesday morning. Analysts are expecting revenues to be down 36.3% to $1.03 billion with results per share falling firm +83¢ last year to a loss of 20¢ this year. I think EQT is better than that. EQT is a buy under $35 for a first target of $70 and a long-term hold for much higher prices.
Primary Risk:Natural gas prices fall.
Freeport McMoRan (FCX – $41.89) reported June quarter revenues of $5.74 billion, just above the $5.54 billion estimate. Higher costs held pro forma earnings to 35¢ a share, a penny above the 34¢ estimate. Average realized copper price fell 5.2% to $3.82/lb while unit net cash costs rose 4.3% to $1.47/lb.
In the June quarter, they sold 1.03 billion pounds of copper, down 5.3% from last year. They sold 495,000 ounces of gold, up 6.3% from last year, at an averaged realized price of $1,942/oz, and 20 million pounds of molybdenum. For the September period, they guided for sales of 1.0 billion pounds of copper, 420,000 ounces of gold, and 20 million pounds of molybdenum.
For the full year, they now expect to sell 4.0 billion pounds of copper, 1.75 million ounces of gold, and 79 million pounds of molybdenum. That’s slightly below their last guidance for 4.1 billion pounds of copper and 1.8 million ounces of gold.
They trimmed their 2023 capital spending estimate m $5.1 billion to $4.8 billion and said they expect about $6.4 billion in operating cash flow this year, after reporting $1.7 billion in the June quarter.
On the conference call (SLIDES HERE and TRANSCRIPT HERE), management said copper demand continues to outpace supply: “The ability of the copper industry to meet this rising demand is a major challenge, and we are working very hard to increase our supplies as we look forward.”
Freeport’s export permit for its low-cost, high-grade Grasberg mine in Indonesia expired on June 10, when Indonesia began its raw mineral export ban. The company has not made any shipments since the expiration. President Kathleen Quirk said they are in discussions now with Jakarta over the export duty.
Freeport has 111 billion pounds of copper reserves. They say if copper averages $4 a pound in 2024-2025, they will have about $7.5 billion in annual operating cash flow. At $4.50/lb, cash flow goes to $10 billion. At $5 it hits $11.5 billion. I expect copper to go well above $5/lb. until new mines come into production in 2028-2030.
Copper price rose about 1.5% today to $3.88 per pound after Bloomberg reported that Chinese authorities are considering steps to ease home buying, with the intention to lift some of the weight off subdued commodity demand from the real estate sector. FCX rose 3.0% to $41.89 today and remains a Near Term Buy under $44 for a $65 target within two years.
Primary Risk: Copper prices fall.
International & Other Recommendations
It is important to hold some non-US assets, especially in China.
Acreage Holdings (ACRDF – $0.20) launched Journeyman THC lemonades in Illinois in partnership with Botanica. The all-natural, vegan, and gluten-free THC lemonade comes in three flavors: Tropical, Berry, and Tart. ACRDF is a buy under $2 for a hold for the Canopy Growth merger and beyond.
Primary Risk: Canopy Growth does not acquire the company.
* * * * *
We are in 1 of these 3 states at any moment
* * * * *
Your using AI to do stuff Editor,
Michael Murphy CFA
Founding Editor
New World Investor
All Recommendations
Check out the complete Portfolio page HERE.
Buys
These are the stocks everyone needs to own because transformative events are happening over the next year or two, and I expect to hold them long-term.
Tech Dominators
Apple Computer (AAPL – $193.13) – Buy under $150 for new iPhones
Corning (GLW – $33.18) – Buy under $33, target price $60
Gilead Sciences (GILD – $79.94) – Buy under $80, target price $120
Meta (META – $302.52) – Buy under $250, target price $400
SoftBank (SFTBY – $24.61) – Buy under $25, target price $50
Small Tech
Enovix (ENVX – $21.07) – Buy under $13; 4-year hold to $100+
First Trust NASDAQ Cybersecurity ETF (CIBR – $45.69) – Buy under $40; 3- to 5-year hold
Fastly (FSLY – $17.65) – Buy under $20; 2- to 5-year hold to $80+
PagerDuty (PD – $24.12) – Buy under $30; 2- to 5-year hold
QuickLogic (QUIK – $8.91) – Buy under $10, target price $40
Rocket Lab (RKLB – $7.81) – Buy under $13, target price $30+
Velo3D (VLD – $2.38) – Buy under $6, target price $50
$20-for-$1
Akebia Biotherapeutics (AKBA – $1.23) – Buy under $2, target $20
Aptose Biosciences (APTO – $4.34) – Buy under $10, ultimate target $300
Compass Pathways (CMPS – $8.96) – Buy under $20, hold a long time for a 10x return
Inovio (INO – $0.54) – Buy under $7, hold a long time
Invitae (NVTA – $1.38) – Buy under $10, first target $50, then $100+
Medicenna (MDNA – $0.42) – Buy under $3, first target $20, then maybe $40
ScyNexis (SCYX – $2.97) – Buy under $2.50, target price $20, then $50
Inflation
A Short-Sale or REO House – ($447,000) – Hold
Bag of Junk Silver – ($25.00) – hold through silver bull market
Sprott Gold Miners ETF (SGDM – $27.10) – Buy under $28, target price $50
Sprott Junior Gold Miners ETF (SGDJ – $30.63) – Buy under $39, target price $100
Sprott Physical Gold and Silver Trust (CEF – $18.74) – Buy under $18, target price $30
Global X Silver Miners ETF (SIL – $27.52) – Buy under $30, target price $50
Coeur Mining (CDE – $3.14) – Buy under $5, target price $20
First Majestic Mining (AG – $6.81) – Buy under $11, next target price $23
Paramount Gold Nevada (PZG – $0.32) – Buy under $1, first target price $10
Sandstorm Gold (SAND – $5.45) – Buy under $10, target price $25
Sprott Inc. (SII – $33.03) – Buy under $40, target price $70
Cryptocurrencies
Bitcoin (BTC-USD – $29,718.27) – Buy
Grayscale Bitcoin Trust (GBTC – $19.59) – Buy
Ethereum (ETH-USD – $1,890.10) – Buy
Grayscale Ethereum Trust (ETHE – $11.50) – Buy
Commodities
Crude Oil Futures – July 2026 (CLN26.NYM – $66.00) – Buy under $65; $200+ target
United States 12 Month Oil Fund, LP (USL – $34.80) – Buy under $35; $100+ target
EQT (EQT – $40.82) – Buy under $35; $70 first target
Energy Fuels (UUUU – $6.04) – Buy under $8; $30 target
Freeport McMoRan (FCX – $41.89) – Buy under $44; $65 target within two years
International & Other Recommendations
EMQQ Emerging Markets Internet & Ecommerce ETF (EMQQ – $30.67) – Buy under $38 for a $66 target in 12 to 18 months
KraneShares Bosera MSCI China A Share Fund (KBA – $26.56) – Buy under $40 for a three- to five-year hold
Morgan Stanley China A-Shares Fund (CAF – $12.68) – Buy under $18 for a three- to five-year hold
KraneShares CSI China Internet ETF (KWEB – $28.07) – Buy under $40 for a double over the next three years
Acreage Holdings (ACRDF – $0.20) – Buy under $2 for the Canopy Growth merger
Mongolia Growth Group (MNGGF – $0.89) – Buy under $1.30; long-term hold
Holds
These are holds but not sells – yet. They could get moved back to one of the buy categories if their prices drop or outlook improves, or they could become sell recommendations in the future.
Arch Therapeutics (ARTH – $2.64) – Hold for buyout
Graphite Bio (GRPH – $2.76) – Hold until they update their strategy
TG Therapeutics (TGTX – $20.95) – Hold for buyout at $30+
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Numero uno
Why don’t the analyst factor into the price of AAPL stock the fact that Apple is coming out with the Apple car? No one seems to mention it at all!!
when will it begin production?
LOL. Never.
Not sure, Apple hasn’t issued any predictions as far as I know. What say you MM? Thanks
MM–On QUIK, please address the negative article posted by Ronald Showmaker at the end of the last board. Thanks.
Morning jgmd,have to say it wasn’t I who posted anything negative about quik don’t own any,have a nice weekend
You’re right. It was Roger in Seattle who posted the QUIK article.
MM–please respond, thanks.
Maybe mm will respond to your question,who knows this newsletter has been put on the back burner,since the moonshot biotech newsletter is enjoying a 106 precent gain off of all the losses this newsletter and membership have accumulated over the past 2 years,oh well as sad as it is,have a nice day
Chris–your pick of ACXP seems nearly a sure thing for its best drug for C. diff, but why has the stock been doing poorly lately? I don’t know where a YMB poster got the idea that the stock is behaving as though the FDA will reject the drug, unless this is FUD sabotage from Big Pharma with established drugs that are inferior.
FUD. The reason the stock has been been doing badly is a slowing enrollment. Between the first and second quarter this year they added only a single patient to their trial. Pfizer received permission from the FDA to get an interim peek at their data because they also had slow enrollment. 2 big reasons for slow enrollment are: 1) they have to enroll within 24 hours of diagnosis and 2) Covid stops people from wanting to go to repeat visits to the trial site for follow-ups. They have continued adding patients this quarter. They need to add fewer than 10 patients before they can get a peek at their data and perhaps stop the trial. We will learn at their next earnings call on August 14 how far they are from that goal. With a market cap of $27M and a drug that is worth $500M, I think it is a steal here. Even if they sell it for $250M, that’s almost a 10-bagger.
Also NervGen is a buy now as we will likely see results of its trial in Spinal Cord Injury in less than a year. You’ll either lose almost all your investment or see a 10 bagger in that time. And even further gains as they move the drug closer the drug closer to commercialization and trial their drug in stroke. NGENF is my biggest holding. They recently got $3,180,000 in grant money to help defray costs of their Phase 2 in SCI. https://www.wingsforlife.com/us/research/a-novel-combination-therapy-for-improving-functional-recovery
Thanks. Slow enrollment is always a major problem. It killed Algernon. Even if/when ACXP has a successful phase 2b, it is only about 20 patients, and I doubt any takeover will be made unless a much larger phase 3 is done. This could take a long time unless a partner steps up to fund it. Certainly a successful phase 2b will pop the stock maybe 50-100% to $3-4, but with high risk of petering out to $2 again. Announcement of a partner may maintain the stock at $3. What are your odds of buyout after only a successful small phase 2b? What are your stock price scenarios?
The peek at the data will occur when 36 patients have been enrolled. Keep in mind that it’s a non-inferiority trial. If all who received ibezapolstat are cured within days and maintain a healthy gut biome (which has so far been the case in prior studies) then even if all the vanc patients are also cured but their gut biomes are wrecked, Acurx will have shown non-inferiority. I expect we will see at least one failure to cure among the subjects who receive vanc. We will just have to wait and see just how good the data will be. If the data is as good as I expect, then I expect a Big Pharma partner to either buy the company, the drug or fund a Phase 3. I would expect faster enrollment in a Phase 3 if they can tell patients, “While the standard drug only works 80 to 90% of the time and wrecks your gut biome, all 30 C. Diff patients who have taken ibezapolstat have been cured within 3 to 4 days with no adverse effects.”
In Pfizer’s Phase 3 for its C.Diff vaccine, they knew in those age 50 and older 286/100,000 persons would get serious C.Diff infections so they enrolled 17,500 patients in their vaccine trial. The plan was to accrue 64 cases in two years, but due to Covid and other problems the FDA agreed to let them peek when they had 42 cases within 4 years. If FDA was willing to consider a Phase 3 for a C Diff drug with only 42 C Diff cases, I think a Phase 3 for ibezapolstat might be fully enrolled in a couple of years (or less with more sites).
We know from history a better C. Diff. drug is worth at least $500M. What kind of discount should be applied to a drug that still needs a Phase 3? Even if it’s a 50% discount, that’s about a 1000% gain from here.
Good points. As you say, “even if all the vanc patients are also cured but their gut biomes are wrecked, Acurx will have shown non-inferiority.” I’ll go further–SUPERIORITY instead of mere non-inferiority.
Should we buy more before or after the conference on Aug 14? Do Big Pharma companies buy mainly after successful phase 3, and how often do they buy after a great phase 2b?
MM?
No ENVX commentary? up $4 and now down $1?
Him too busy working on new biotech letter.
Envx,Looks like a pump and dump,only showing revenues of 43,000 for the quarter.Since 22 percent of the float is being shorted,that little bit of optimism for the future seems to have been the driver today,that plus the market being up Hugh in the morning must have been the culprit,
The Radar Report for 7.27.23 is posted. I raised the buy limits on ENVX to $19 and on SCYX to $3.