Replies to post #56731 on Ariad Pharmaceuticals Inc fka ARIA

[biotech_researcher]

Zuize, call me crazy, but usually the FDA would want the completion of the enrollment before making a decision on approval

[trading_cyclist]

All true, Zuzie.

Also, if I've interpreted the guidance of FDA's website correctly, the "Breakthrough Therapy Designation" can take advantage of both the "accelerated approval" and "fast track approval" mechanisms. I may have the wording wrong, but I got the distinct impression BTD is the fastest route to approval (although by no means guaranteed).

Also, and this for everyone, my intent was not to predict an approval date, but simply to suggest a possible range of dates based on the prior experience of other drugs that have received BTD. Sincere apologies if there was any misunderstanding regarding the purpose of my post.

kind regards to all,

TC