Takes FDA up to 60 just to accept the NDA once its submitted, THEN if given Priority Review you then have to wait up to 6 months for the The Prescription Drug User Fee Act (PDUFA) date.
You forgot to mention all the news. And btw we are talking about a $5+ stock.
Data From METEOR Pivotal Trial of Cabozantinib in Advanced Renal Cell Carcinoma Accepted as Late-Breaker Presentation in Presidential Session at European Cancer Congress 2015Business Wire(Mon 8:31AM EDT)
FDA Grants Breakthrough Therapy Designation to Exelixis’ Cabozantinib for the Treatment of Renal Cell Carcinoma in Patients Who Received One Prior TherapyBusiness Wire(Mon 8:30AM EDT)
Yeah I just made that up...We love to think a small low price stock, that is volatile anyway, is protected from the big market trends. Its not. Just goes to show, despite being a great potential stock, somewhat "insulted" from market bad news, you still have to watch the mega trends. Take the opportunity when it happens, keep some dry powder for days like this. Consider if you made good stock purchases every time the market crashed in history, you would probably be a millionaire if not a billionaire. Hold Tight.
IBB is falling hard, over $20 down in pre-market. Do not sell into this drop -this will pass and bounce back. There is nothing fundamentally wrong here. HOLD TIGHT.
Here is easy to understand picture, there are many others. http://www.chem.purdue.edu/shah/research2.html
Type Value Conf.
resist. 1.72 1
resist. 1.49 4
supp 1.09 5
supp 0.98 2
supp 0.92 2
supp 0.85 2
supp 0.54 2
supp 0.44 12
supp 0.34 4
supp 0.27 6
supp 0.18 4
And now I am tellding the entire message board to put you on IGNORE as I am doing now. Get lost shorty.
If you want to watch the elevator with your boys, that's fine, but talking about bribing a person by name is frowned upon on the net. IR reads the MB you know. Caution, you are leaving a record for the SEC to find if you get reported for attempting to secure insider information.
""Our proprietary SIGMACEPTOR™ Discovery Platform produced small molecule drug candidates with unique modes of action, based on our understanding of sigma receptors. Sigma receptors may be targets for therapeutics to combat many human diseases, including Alzheimer's disease. When bound by the appropriate ligands, sigma receptors influence the functioning of multiple biochemical signals that are involved in the pathogenesis (origin or development) of disease."" Now there are 8 different pipeline drugs. I assume are all a result of the SIGMACETOR Discovery Platform- it is somewhat over looked and really a great source of new drug small molecule discovery that is probably worth Multi-Millions if not Billions. And that's value NOW, not accounted for in the share price.
Keep in mind we are not just talking treating the symptoms with greater efficacy, but disease modifying -something no other drug has displayed. This will be first in its class, one of a kind, with full patent rights until 2035.
Just wondering if the contract is needed to start the mock inspection or signal the mock inspection was completed and accepted by ACAD. ie NDA package completed including the Manufacturing QA? At any point we are getting closer to the NDA.
Not a bad time to buy some ACAD, but no telling if the down trend will continue after a dead cat bounce. No matter it will head higher. Consider a position in AVXL, very cheap (small molecule like ITCI and ACAD, Alzheimers Disease Breakthrough for increased efficacy and disease modifying), my feeling is it's like buying ACAD for $1.50 back in the day.
To me this is so-so"news", we already knew they were in Switzerland, this is more like an extension of a contract in a way. Good yes, it may help the stock reverse, but will it give ACAD legs to get into an Up Trend?