Go it alone? I know it seems like it's on auto-pilot, but the company still has to submit a NDA to the EU probably next year and they have to start thinking about distribution not just to the USA , but World Wide. Thats a huge task and expense.
Priority Review is a no-brainer. The FDA has been waiting for this drug for a long time. Very unmet need and frustrating condition to treat.
So how much could they make ?
1000000 PD patients...approx 40% will get PDP. So thats 400,000 PDP patients. Price for Abilify is 13K/year...I think NUPLAZID will be higher...guess is $15,000/yr ( ~ $40/day). Now lets say of those 400,000 patients, only 20% get placed on Nuplazid first year. That's 80,000 patients on treatment....so 80,000 x $15,000/yr, so for the first year, we are talking 1.2 Billion with only 20% penetration. Remember , this does not take into consideration OFF LABEL use for any other condition or if /when it may get an indication for another type of psychosis/ sleep issue/ Autism etc. Now consider there are 1.6 million PD patiens in the EU, and 640,000 will get PDP at some point. We are talking way over a Billion in the EU also.
NUPLAZID/Pimavanserin is ONE OF A KIND, FIRST IN ITS CLASS drug to treat Parkinson's Disease Psychosis (PDP). And ACAD owns the World Wide Rights to it. The FDA has already reviewed the Phase3 research data and given ACAD thumbs up to proceed with the New Drug Application and has given Pima " Breakthrough Therapy Designation " USA sales will be over 1.1 BILLION and European Union will be well over a Billion as well. There are several other ongoing studies.. The manufacturing arm of the NDA is getting the close attention it should of had last year- it will take some time for new directors & CMO 's to get the systems ready & on line for the FDA evaluations. ..Review the catalyst list-
1) New CEO -SEPT 3,2015-Steve Davis as President and Chief Executive Officer. - who can led us to Drug Approval and move the company forward.
2) Possible Partnership with a MAJOR drug company that will assure the NDA will meet and exceed all the FDA standards.
3) NDA on track to be submitted in the 2nd half of 2015. NDA is complete, manufacturing quality systems on track.= SUBMITTED NDA TO FDA SEPT 3, 2015.
3) 60 days for the FDA (Food and Drug Administration ) to accept the application by about Q1 2016.
4) Upon potential acceptance, FDA could also grant priority review.
5) With priority review, six months pdufa date (Prescription Drug User Fee Act ), without, 10 months. Best guess is July to Oct 2016.
6) EU ( European Union ) filing 6- 9 months post FDA filing. Perhaps Q2-3 2016. Large unmet need in EU.
7) ADP enrollment (019 study) complete by 2015 Q4 and data by about Q2 2016
8) Schizophrenia maintenance trial to commence 2nd half of 2015.
9) Sleep Study to begin 2nd half of 2015.
There are NO ongoing issues with the FDA.
Strong hands pick up the cheap shares due to unchanged AVXL fundamentals. I hope to gather a few shares myself tomorrow or Friday. I would be surprised if shorts hold it over the Labor Day Holiday.
With so many retailers involved here, tree shaking is easy for the MM to get some shares. Hits a few stops which only weak minded rookies use drops the price. Not worried, as soon as it gets too low to ignore the buyers will be back in full force.
Too many good bargains in biotech with the sector sell off. But to me this failed deal tells me ARIA is worth at the minimum, about $10+. Baxalta not willing to make it work is just part of the game, they could come back or simply look at other biotect oncology bargains, like EXEL, ARRY. Perhaps other forces at work here didn't want the deal anyway. Bottom line ARIA is now very undervalued.
"As well as disagreements over price, Baxalta also backed off after receiving negative feedback about the prospect of a takeover of Ariad from some of its own investors, one of the people said."
So by posting this are you thinking 2-73 could be a treatment for Prion diseases....interesting thought, that's thinking out of the box. Nice. But a difficult disease to study. No one would want to be around any patients with a Prion disease. Even Pathologist don't want to do autopsy's on bodies of suspected "infections".
It's a protein that can cause deadly diseases like Creutzfeldt-Jakob Disease. it is not a living organism, but you can consider it "Viral-like".
I am seriously considering putting you on IGNORE if you put up one more post like this. You are welcome to enjoy your "Freedom of Speech", but remember it's not "Freedom of Speech without Consequences".