RE:RE:RE:RE:Clinical Trial Size in Orphan and Rare Diseases Wow so muchg copying and pasting... Have you actually been in an FDA meeting Noteable..?
Fast Track designation is NOT same as Breakthorugh Designation... and without a confirmed biomarker that shows statisically that presence of the biomarker translates to efficacy, then accelerated approval is just an aspiration.
ONCY has never spoken about soliciting the FDA for AA... it's just you and the pumper crowd stating your wishes as facts...
It would be wonderful to get this...so why does Prof Heineken and our very own Matt the Hoople only ever talk about starting a Phase III.... AA is not Phase III, it's Phase IV.
and so the analysts revise their targets down, the share price continues to crater and the rest of the market is seeing new highs... it's only you and a handful of unicorn whisperers that believe this company is the holy grail of investments.
What will you be saying by mid year when there is still no partner in sight ? What do we have now, 3 trading weeks left of 2023... interest in ONCY is anaemic.