FWIW I listened to the CC again and what stood out to me was the EMA “pulling” Anavex into submitting for approval. Why now, why Anavex? Why the EMA only and why hasnt the FDA, who has seen the same amount of data, felt compelled to “pull” them into submitting an NDA? Or…have they?
At first thought I felt like going down the corrupt Fda rabbit hole with my thoughts but then it donned on me and I realized that actually the Fda may have pulled us in but is on thin ice here. We all know the crow they are about to eat based on their desperation approval for a drug that barely made it on the market for a year+ before being “pulled”, talk about being “pulled”! Lol.
Anyway they have to navigate the corporate tapdance with those that have invested/wasted billions of dollars and hundreds/thousands of lives in the process. This being said I see Lequembi being approved as the final “ok, now we are even” last ditch “backscratch” so to speak. The last ditch effort to save face for a greedy, blind, wasteful dead dynasty of mabs. This is where we are being pulled by the Fda comes in.
With the final mab that ever gets to soon to be approved (combo therapys aside) the recent relaxing of the endpoint criteria is, imo, in essence a direct “welcoming” or “pulling” of our drug into submitting an NDA asap. They have to approve Lequembi and then its all hands on deck for Blarcasamine. These things take many months to contemplate and draft so this has been in the works for some time, again imo, maybe 2+ years? Now rethink about who just joined our company that came from the Fda, any coincidence he joined our tiny company over 100 others?
I think it is safe to say the Fda has been keeping an eye on their “pet project” from its first inception of the ph 2a adaptive new trial protocol THEY designed and that WE ran way back from 2015. Yes, it is not only the EMA that is hungry, it is also the Fda that wants us to submit and I wouldnt be surprised if this gets into a “bidding war” of who gets to actually approve the next big blockbuster Alzheimer SOC first. AA anouncement would be fine with me.
Stay tuned my friends, popcorn in hand with a front row seat!
Tred
