RE:RE:RE:RE:RE:RE:RE:RE:BTD timeline...Again, the question to your subposition is has Theralase established open communication with FDA with it's Fast Track and got a Rolling Review.. so that the scenario you just outlined below is avoided.
Your subposition reads like TLT is sitting pouring coffee with a usb key waiting on a 'package of data' rather than having a Rolling review.
The data should already be presented to FDA on a Rolling Review.. any critical questions FDA has can be answered by TLT as they go along.. as it's understood trials have endpoints for individual patients as the months upcome.
Any further talk on 'decision's here on this board is POINTLESS without Management Answering this question.
Yes I do really like Dr.Vera's addition..
ScienceFirst wrote: TLT could, on its side, delay this, if it wanted to put all the chances on its side and add 12 more patients to the negative impact of the first 12 undosed, so they could present data on the first 37 patients. That's an option they could give to themselves to ensure that the % of efficacy are to its advantage.
But Eoganacht showed that even with the first 25, our chances are good as the % of efficacy still above competition.
It's an tough and important call as you only have one chance to make a good impression, so don't spoil it.