<<That would be the "nuclear winter" scenario, with the lead compound dead and the company broke.>>
Gfp--I can only imagine what you might have been writing had Stoll not been so positive and near-ebullient:
I have probably published more about the FDA's inconsistency and irrationality than anyone else in the world, literally. But this angst is getting a bit overdone, IMHO. Even before the electron microscopy data was in, Stoll was confident enough about the toxicity/FDA situation that he did just a small PIPE. He's not foolish enough to say he is certain the FDA will agree, but everything that can be read in and between his words tells you he is very confident. And that is not his inherent nature, Roger Stoll quite easily comes to contemplate the negative possibilities. The odds of success in the FDA deliberations are higher than they have been--or will be-- for any clinical trial Cortex has ever run.
So I will say this definitively right now--that nuclear winter scenario cited above is not going to happen. Even if the 10-20% (in my estimation) possibility of FDA noncooperation comes to pass. They will either have $11-12 million in the bank by then, or they will have $6 million plus an inlicensed compound. Along with a small ($3 million?) upfront payment on a high impact R&D agreement with a BP (which would also reduce their burn, since those expenses would be shifted to the BP) they would have enough to get CX701 into the clinic, and run a small Phase II on an inlicensed drug. Those events would also allow them to do another PIPE. I don't think the terms, after those events, would be worse than they are now. Even if CX717 were shot down, they might be better. Organon will have started its spinoff, one might hear some news about Org24448.
I am not joining the Dysphoria Express. I can live with 80-90% optimism that the FDA will give CX717 the go-ahead. In which case all nuclear season forecasts go out the window.
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