RE:RE:RE:RTFht, and as a final laugh at all the pathetic bagholders on this MB i will leave you with this tibbit:
"Orphan drug and Fee-Waiver designations however, did not lead to similar outcomes
with only 33% and 12% first-cycle approval rates, respectively."...go find the study yourself
..again only scumbag fraudster bagholders acccuse me of being a basher (they are 100% wrong which is why i own them and can treat them appropriately) but this data is data that owners of TST should know inside and out (not knowing makes you a bagholder) i admire the current TST leadership moxy but...ps i don't even forecast a Not Approvable i am more in the Approvalable camp or maybe Approved with a PIV trial type restriction...but who knows, that is playing the "unmet need" part which i don't know how much that comes into play into any RTF process (ps find that stat yourself but "unmet need" therapies have a higher rate of Approved)