What would I give to learn of the extent of involvement, in this FDA application ? - by Memorial Sloan Kettering and the lead doctor in this trial - Dr Jonathan Yang.
The application, we know for an FDA Fast Track approval may consist of 40 pages of content.
Much more must be contained in the application than the ASX release of many months ago involving just 9 patients - (I am not suggesting, it is appropriate for the general release of new information)......but the fact of the matter is - the FDA has granted a Fast Track, for a drug that enhances RADIATION.
Of course not - despite the Fast Track........it does not mean FDA approval is anywhere near close, but just think - even dream of the possibility of paxalisib improving radiation treatment for cancers, around the world.
The FDA Fast Track does however, I believe - mean that investors can rightfully harbor real hope of what paxalisib might do, with radiation in cancer. A share price of proportions that cannot be imagined, would surely follow.
If you think the FDA is the king maker in this drug development game (it surely is)- than what I have said is real, alright.
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