Tuesday, April 09, 2024 9:09:28 PM
As Druggie said, I do stir the pot, I acknowledge not being an expert, but like to hear from others who are, but in plain, understandable English.
I don't believe that you need to be knowledgeable in the field to be successful in investing in it.
It's been over 40 years since I was first surprised by FDA action. All the world was certain that Genentech's THC would be approved by the FDA. Having little to invest, I bought options that should be well in the money after approval. Rather than approving, the FDA asked a question that had never been discussed in the design of the trial, it couldn't be immediately answered, and approval was delayed for some time, and of course my options were worthless. Of course we know THC was ultimately a blockbuster product, but I learned the lesson that you cannot be absolutely sure what regulators will do, at least not in the short term. In the long term, no drug that I felt certain of approve didn't gain approval, but some like THC had delays caused by the regulators, mostly FDA, but others too sometime don't do the expected.
If I were to put a percentage on it, I'm over 90% certain we'll be approved without a serious delay. I would suspect that if Analysts had been asked about THC being approved on initial approach to the FDA over 90% would have practically guaranteed it.
Gary
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