For the newbies, thanks to the.croupier. Thank you.
1. Filing of the NDA (New Drug Application NUPLAZID™ = pimavanserin) in the first quarter of 2015.
2. 60 days for the FDA (Food and Drug Administration ) to accept the application.
3. Upon potential acceptance, FDA could also grant priority review.
4. With priority review, six months pdufa date (Prescription Drug User Fee Act ), without, 10 months.
5. Sleep disturbance trial for PDP (Parkinson's Disease Psychosis ) patients to commence in the first half of 2015.
6. EU ( European Union ) filing 6- 9 months post FDA filing, so around 3rd quarter.
7. Potential top line ADP (Alzheimer's Disease Psychosis ) in fourth quarter of 2015 or around end of 2015.
8. Schizophrenia maintenance trial to commence 2nd half of 2015.
9. More information on Pima ( NUPLAZID™ =pimavanserin) for Autism 2015.
I am always interested in biotects, but I would never put any significant money in a $1.70 stock. you can lose 20-50% of your investment in the blink of an eye, it has already popped up. Sell the news.
BTW I had been looking for another small MK biotech like this with AD, PD, MS, ALS research studies etc , but I couldn't find one. Looked at a few but nothing worth an investment.
BTW Lindquist is private- " Tony Coles, the chief executive who sold Onyx Pharmaceuticals to Amgen AMGN -2.3% for $10.4 billion in 2013, is starting a new company that will use yeast to try and discover new treatments for Parkinson’s, Alzheimer’s, and amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease.)
The new startup, Yumanity, will be based in Cambridge, Mass., and is built around technologies developed by Susan Lindquist, the former director of the MIT-affiliated Whitehead Institute for Biomedical Research. Three researchers who worked in Lindquist’s lab will serve as founding scientists for the company, which currently has five employees. Coles says he hopes to scale up to 25. "
Oil...ah no direct relationship, but when any negative major market conditions occurs people get nervous and go to cash. Not a problem I would bet if you sold today you will be buying it back before the end of the week.
Interesting article by Forbes - PHARMA & HEALTHCARE 12/15/2014 @ 9:34AM 2,544 views
" Biotech Entrepreneur Tony Coles Takes Aim At Parkinson's And Alzheimer's ". Looks like Lindquist Lab and ACAD would be a good match.
I understand some think a Cramer recommendation is a kiss of death...but here's my thinking on this. If he is going to give a bullish recommendation on ACAD then most likely The Street is not going to release their typical " party is over Hit Piece ". And could be The Street might give positive mention soon.
In the Lightning Round, Cramer was bullish on TrueCar (TRUE) , Acadia Pharmaceuticals (ACAD) , Southwest Gas (SWX) , Twitter (TWTR) and Procter & Gamble (PG) .
1,000,000 PD in USA, 400,000 PDP will need treatment, x $30/d x 30d/mo x 12 mo/yr.. Another 1,600,000 PD in EU.....Oh my I can't count that high.
Listen to the last 2 web casts. I believe Uli explains it. Suffice it to say Pima is a One of a Kind, First in its class specific for Parkinson s Psychosis. Many of the currently used anti-psychotics have great risk to worsen the Parkinson's patient due to side effects.