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   Biotech / MedicalBiotech Valuation


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To: JamesK who wrote (52134)4/14/2025 12:36:28 PM
From: Art Bechhoefer
1 Recommendation   of 52153
 
The FDA recently terminated 800 employees responsible for approving new drug applications. Is it any wonder that biotech stocks, which thrive on new drug approvals, are down?

Art

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To: Art Bechhoefer who wrote (52137)4/14/2025 1:33:09 PM
From: DewDiligence_on_SI
   of 52153
 
investorshub.advfn.com

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To: DewDiligence_on_SI who wrote (52138)4/18/2025 8:39:42 AM
From: JamesK
   of 52153
 
I have no inside information. Drug development is slowing down after FDA cuts.

wsj.com

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To: JamesK who wrote (52139)4/18/2025 3:12:21 PM
From: DewDiligence_on_SI
   of 52153
 
At any given time, there are likely to be a few small biotech companies who have legitimate beefs with the FDA. I'm not fully convinced that this problem has become markedly worse in the past six weeks or so.

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To: DewDiligence_on_SI who wrote (52140)4/18/2025 3:37:20 PM
From: JamesK
   of 52153
 
I understand. We could both post media stories. As a biotech investor I'm waiting more to see what direction they go with things rather than worrying about whether they have enough reviewers.

It'll take some time there to see what happens.

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From: Aloner6/6/2025 9:11:15 PM
2 Recommendations   of 52153
 
IBRX is up more than 50% over the last 30 days and still 50% below it's 52 week high. The FDA approved their drug ANKTIVA, for NMIBC, the only drug for the treatment of Bladder Cancer, with a 80% success rate, in December. They were just approved to treat Lymphopenia for Pancreatic Cancer with the same drug. They went with Trump to the Middle East and licensed their drug to the Saudi's with Trump in the room and approving the deal. Strong balance sheet, strong quarterly report. Book value is currently $2.6B. The number of new patients with NMIBC in the US alone is 61,000 per year, the fourth leading cause of Cancer in Men. Now there is a treatment.
Conduct your own due diligence, but you should do it before they get bought out.

immunitybio.com

And speaking of Bladders, UCLA just accomplished the first ever Bladder Transplant on May 4th.

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From: JamesK7/31/2025 10:29:47 AM
1 Recommendation   of 52153
 
Both ARGX and ALNY had blow out earnings today. Doesn't seem to help the industry much though.

ATTR-CM looks like a gigantic market. ALNY BBIO PFE

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From: A.J. Mullen8/5/2025 9:54:45 AM
   of 52153
 
Vertex cancels its non-opioid pain-reliever, barrons.com. That's bad news for more than stockholders.

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To: A.J. Mullen who wrote (52144)8/5/2025 12:27:10 PM
From: A.J. Mullen
1 Recommendation   of 52153
 
I was in too much of a hurry. Vertex has cancelled their follow-on to Journavx, which is already approved for acute pain, However, they got bad news from the FDA this morning regarding broadening the label for Journavx, fiercepharma.com “at this time, the FDA does not see a path to a broad indication,” Kewalramani (CEO of Vertex) said.

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To: software salesperson who wrote (52136)8/5/2025 3:06:18 PM
From: Ian@SI
   of 52153
 
Alan,
An increasing number of researchers, now believe that amyloid, beta and tau are a part of the brain’s immune system. Suppressing them is more likely to allow the pathogens that do cause Alzheimer’s to more easily attack the brain then it is to produce any benefit.

Leading edge, researchers have discovered several pathogens which contribute to Alzheimer’s disease. I believe that most people here are aware of the 2008 Report in clinical trials.gov and In pubmed Has conclusively shown that people with herpes who were aggressively treated with an antiviral are up to 80% less likely to get Alzheimer’s than those who received no treatment for herpes. The virus that causes chickenpox also leads to shingles after 40 years and if you’re not aggressively treated will lead to Alzheimer’s after another 20 to 30 years. People who get Gingivitis are also prone to get Alzheimer’s. There are also some fungi and parasites which may contribute to Alzheimer’s This research is in very early stages and more evidence is needed before that can be made as an absolute statement. Research is underway to see whether getting rid of those pathogens will also act as a treatment for Alzheimer’s But the last time I checked, it was too early to get any definitive answer.

There are about 98 phase 2 and phase 3 clinical trials to get rid of amyloid, beta and or tau which have failed Outright after completion Or failed due to futility during a scheduled checkpoint. On the other hand, The Biogen Drug aduHelm, Which had two phase 3 clinical trials, one of which failed miserably and the other showed no benefit And has been withdrawn from the market as no insurance company would cover the costs And very few doctors had any interest In it and three members of the advisory committee resigned in protest.
The FDA is desperate to find something that they can approve in the Alzheimer’s area And have actually approved a couple more drugs, which tested very, very early stage Alzheimer’s. i’d be quite surprised if either of them is able to reduce the incidents of Alzheimer’s or provide any treatment for existing disease that isn’t early stage

if you use any of the AI tools, you can get excellent answers to whatever level of detail you desire. The two that I use and that I find most helpful are ChatGPT and Gemini if you use something else, I’m sure they will give you accurate information as well.

Best regards,
Ian

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