Both are neurological conditions associated with psychotic symptoms in some cases. In theory pimavanserin should be effective in ADP - and I think it will be. That said, there is always clinical trial risk... High placebo effect, etc. that can derail a trial. So if I am acad I would not want to chance a questionable result prior to getting PDP approved. The data for PDP are so strong that the FDA didn't require a second confirmatory Phase III. That's saying something. I own a massive amount of acad because I believe in the medication and understand the market need for a drug like this. I hope it works in ADP and think it will be there's always a chance it doesn't and if it doesn't let's get that result after the drug is on the market for ODO. Not before.
You guys realize that the delay was on purpose, right??? It was a mistake to run the study in the first place prior to approval of the PDP indication. Too much clinical risk as it would call into question the data with a poor outcome. It is simply not done and I was shocked when ACAD was pursuing it so aggressively without being on the market first. And they clearly should have been more focused on the NDA for PDP. Pimavanserin has great data, breakthrough status and doctors are waiting for novel antipsychotics. And it should be efficacious and safe in ADP. Just lets get the medication on the market first!
Per NASDAQ, they were not in the top institutional holders listing as of 12/31/2014, now they are in the top 10. Not sure how much they added but compared to December a lot.
Wow. I can't read all this. I deleted the prior posts when no one could find them because I got freaked out that I was talking about something that was only released to Cowen clients. Then Chevy posted that it was released on the Cowen Research site so phew. Sorry you don't believe me. The note did go out via email. Honestly it's just an analyst lunch so really didn't think it would create a controversy. I'm a pretty honest guy actually. Well I try to be anyway. Haha. Can we put this behind us?
Oh just re read the last line. Yeah. I hated doing LPs. Probably why I am a psychiatrist and not a neurologist. That and I like people. Haha.
Hey you're a doc too? Did not know that. I thought your example seemed pretty specific. Makes sense now. Interesting. They couldn't do an LP in the ED???
--Management really screwed the pooch on the NDA filing. No debating that. They have had the great data since 10/2012 so really no excuse. I think Uli must have been trying to sell the company rather than do the work needed to get the manufacturing stuff in place correctly. I think he must have thought he could sell but being a crazy founder type probably wanted too high a price when it was in the $20s and big pharma called his bluff. So Uli never got his price and you know the rest...
--pimavanserin has been derisked. No clinical risk in PDP. We are just waiting for the NDA to be filed. The molecule is effective and clean. And that is more important than the delay
--Psychiatrists - like me - are in great need of a non-dopaminergic medication to treat psychosis. All antipsychotics have terrible side effects from tardive dyskinesia/EPS, metabolic syndrome, QT prolongation, and dystonic reactions. Not to mention an FDA black box warning of increased mortality in the elderly. This requires every psychiatrist to have a discussion - often multiple - with patients and family that "yes the benefits of treating psychosis really are worth risking death..." Often this is the case however wouldn't it be nice to not have that FDA black box? If pimavanserin avoids this in it's label, that would be huge.
--ADP and other trials if positive will push stock much higher
--pimavanserin treats psychosis which is a symptom and not a diagnosis. Also appears helpful in sleep. Many antipsychotics are prescribed off label. Pima may be tried in disorders off label. It might be as simple as getting a prior auth so patients would need to only fail one atypical first
--Does anyone know how big Abilify was at peak? Did it reach $7B? I dunno but it's at least $5B. Pimavanserin could be bigger. Right now at $3b mkt cap it's 3x peak sales of $1b est. What if it's $5B peak? 3x peak sales is typical back of napkin valuation in biotech.
Back up the truck!!!!!
Sentiment: Strong Buy
The note went out this morning so the fact that it says yesterday probably means it was yesterday since the note was dated today. Unless they had a typo in their note. It's on twitter as well. I was not at the meeting so I don't know. Never said I was at the meeting. Never implied I was at the meeting. Just trying to help the board. Isn't that the point of a message board? Should we not be helping each other share information? Maybe I'm wrong?
Wrong. The article that is 'catching up with..." was from this morning. So you are incorrect in your assessment that I'm a liar. Turns out I actually have a job, family and a plethora of other things to keep me busy during the day. Hence my "silence". You went off on me when I was telling the truth. Maybe I dunno try decaf? Haha.