I think some people (understandably) don't understand how the regulatory process works. The NDA is actually a document that has been added to contiuously from the IND on - the same eCTD document just sees more and more information added. Ultimately the eCTD that is submitted for commercial approval (the NDA in FDA parlance) includes all the bench study, the animal study, the p1, p2 and p3 human clinical data, and includes all the CMC information (chemistry, manufacturing, and controls.) Along the way, the company asks for (and pays for) meetings with the agency to ensure its trials are designed well and outcome measures meet the agency's approval. Anavex has been meeting with the FDA, EMA, TGA, CFIA, MHPRA, etc. from the start. It has guidance and continues to seek it as necessary. Anavex is not simply doing whatever it wants and hoping that it will be good enough, it has already verified that what it is doing is good enough assuming certain criteria (agreed upon by the FDA already) are met. What we heard earlier this week is that, essentially, approval is coming without a second P3. The risk is burned down to as near zero as you can get for 2-73 and we are witnessing, IMO, the capitulation of the short side because there is no more money to be made in that direction.
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