...this NDA acceptance has just become almost as important as the approval itself ? We all know that if the NDA is accepted (regardless of priority status) the share price is going to be a lot higher by the time the FDA will even have to make a decision. But now we also know that a priority review not only shortens the review period by 4 months but it will also mean more money in the bank for titan. It seems to me that after the terms of the deal have been disclosed, now the NDA acceptance with priority review is the REAL catalyst. We should find out soon (in a few weeks max) the type of priority review and if i was right that if we get priority review then the share price should move up even more then the partnership deal did.
I tend to believe the acceptance of the NDA is pretty important as Titan is a small company and it is relatively easy to fail to meet the tremendous administrative requirements of the FDA. it will be an important step and milestone and will validate (or not) the competency of Titan's management.
Yep...Dec 28th is the date when we will find out if it is going to be priority review or not. As for the acceptance of the NDA, I think the application has been accepted for review already since we are now past the day 45 and no word yet from the FDA of a rejection...usually the FDA notifies the sponsor well in advance if it's a RTF letter. In my view the only minor risk now is if we get a standard review only..if that happens then it is possible that the share price will retract a little which for me would be the best buying opportunity ever since I don't mind waiting 8 months instead of 4 (2 months almost passed already since the filling)