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Biotech / Medical : Immunomedics (IMMU) - moderated
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To: luckydog88 who wrote (63114)5/14/2025 5:20:45 PM
From: stockdoc7710 Recommendations   of 63285
 
Approval by Japan is a huge vote of confidence in elevydis. The Japanese are notoriously conservative with drug approvals. They had the benefit of an additional year of follow up data over what the FDA based its AA on last year. Roche has rights in Japan and worldwide with SRPT due 15% royalties. The big one is whether Roche can get approval in EU which supposedly should be ruled on by end of year. SRPT is trading as if the FDA is going to pull the approval for Elevydis. I just dont see it. The new guy that RFK put in charge of the gene therapy approvals is a whack job, but for him to pull approval of a drug already on market would require a full review and process. So far he has not even hinted at doing such a thing. The moms of these boys would go absolutely balistic if the FDA even hinted at pulling this drug. At this point the originial four kids are now 8 years post gene therapy, and there is a large body of evidence that the gene therapy works outside of the formal trial data. While it is correct SRPT missed its primary endpoint it did reach multiple secondary endpoints, and the totality of the evidence is what prompted Peter Marks to grant approval to SRPT. It is this totality of evidence that is the key, not whether primary or secondary endpoints were met. In the next six months it will become clear that the FDA is not going to destroy SRPT and I expect the stock price to rally significantly. They will do 2.6 billion in sales with net income of at least 1 billion dollars. They have a billion in cash and the market cap is only 3.5 billion dollars. This is a huge disconnect, which is why I am not selling.
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