Zuzie is correct (again). The FDA makes clear that even drugs in phase I trials can be accelerated to full approval through this program.
The important points on which all reasonable people are likely to agree are:
1. AP26113 is an amazing molecule by all accounts, and has tremendous life saving potential.
2. It is one of only 58 molecules (57, but let's not get into that here) that has been promising enough for the FDA to elevate to Breakthrough Therapy status (many applications have been rejected).
3. Not only is this reason for hope on the part of cancer patients and their families, it is potenrially game changing for Ariad and it's investors (and count me in). Revenue in YEAR ONE of approval could be on the order of 350m, this based on CURRENT crizotinib sales...and that is for just one indication.
4. There is now evidence to suggest additional indications for AP26113, thus the potential for multiples of crizotinib revenues.
5. Given the FDA's rules for approval under breakthrough therapy Designation, and the experience with other molecules previously given BTD, approval could actually happen as early as JANUARY OF 2015.
6. Only a madman would initiate a short position against this equity, and I am confident that those currently stuck holding such positions are frantically looking for an exit ramp (which may explain some of the irrational posts we have seen cropping up here recently).
Kind regards to all,
TC
