...is most likely to help FDA answer questions around what kind of label to give pimavanserin. If it avoids a black box, then this is a multi billion dollar drug. And even if it doesn't avoid the black box, they have to put in special labeling about risk of death may not be tru for PDP patients. In fact, I think the labeling is what the FDA wanted the adcom for. To answer this specific question. Not approval.
Sentiment: Strong Buy
Oh I mean 17 mg vs 20 mg tablets not dose. They take 2 daily. Question is still valid. I think it's a non issue but want to make sure.
Can anyone tell me why the dose of pimavanserin they filed is 17 mg when they did the phase III with 20 mg? I am a shareholder and long time bull. If you guys know please help me understand this. Thanks!
My patients are not relevant. I work at a college counseling center now and have a private practice so I don't treat PD patients. I trained at MGH where I had many patients in the hospital during my CL rotation. What I would tell you is that PDP is real. Everyone treats with seroquel and it is just okay. Pimavanserin could really change things. Non dopaminergic mechanism.
Agreed. Not a fan of antipsychotics for sleep. That said quetiapine is used often though would be used less if not generic. The only way pimavanserin will be used is if they do a specific sleep study in elderly and get an indication. Could happen. But it's all gravy at this point.
With approval. Most of the decline is not specific to the stock. We are closer to buying more than selling. Hold on. Be patient and if possible, buy more on the way back up.
All will be fine with approval. In the long run oil has no impact on the IBB. In the short run it causes acad and other real biotechs to go on sale. When people return to the group - and they always return - they will want to own a name like ACAD. The earnings Pima should throw off is significant to this company.
What is delaying the trial is that ACAD needs to get approval of PDP first. No additional data that could even possibly cast doubt on the PDP indication should result before PDP approval. I never thought they should have started that study when they did. Uli and the gang should have been working overtime to file the NDA instead. Dang. We should be on the market right now with a $75 stock...
The FDA calls an advisory committee then they need help interpreting the data. So they call in a panel of experts to help answer any questions they have. Calling an AdCom seems like a complete waste of time in this instance.