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Bourbon_on_my_cornflakes

07/17/23 10:36 AM

#423209 RE: nidan7500 #423201

Anyone still wondering why Dr. M. just hired a bunch (most) of FDA tech senior leadership while he simultaneously partnered w/THE AI frat bros @Ariana. We might be looking for a new road map-skill set (not ole schoolers in WS) to start giving signals on the future of the W/S-BP-NIH-FDA compass



Well we could make it perfectly clear by getting an NDA filed for Rett in the 3rd quarter.

tredenwater2

07/17/23 1:20 PM

#423246 RE: nidan7500 #423201

Nidan, could it be that time was needed to prove out not just efficacy better than SOC in AD and Rett, where there was no drug available, but rather disease “midification” like we just saw with Rett Syndrome 5 mg trial? It my theory is correct we should see the next Adult Rett syndrome trial with disease “modification” and then the Pediatric and or Alzheimer trial.

Is this the “we will understand once we see…..” comment?

What does disease modification do, expand the label at approval? Accelerate prophylactic use?

Patiently waiting?

DoTheRightThing

07/17/23 1:32 PM

#423250 RE: nidan7500 #423201

To anyone new, don't get your hopes up reading these type of posts. They come across like an advertisement almost.

AVXL apparently always has this secret grand plan in the background, ready to be deployed "imminently". In reality, nothing happens other than the share price drifting lower and lower