RE:RE:RE:RE:RE:How does Accelerated Approval work In a presentation late last year, a fireside chat I think, Matt stated that the Phase III for mBC would be a standard double blind study. Dr Heineken stated that the bracelet-1 trial was not designed for statisical significance..? kinda begs the question why run the effing thing then, but hey ho...
There will be NO Accelerated Approval... if it were a possibility, ONCY management would have signalled this long ago. Funny how no analysts ever asked that question either... seems its just Notable who would have everyone believe its a possibility...
How long you been posting about billions of dollars for a buyout Notable... is it 3 years or 4 years now... and how has the stock performed in that time... IND-213, ONCY's go to Phase II mBC trial, started in 2012... there is something wrong in the state of Denmark folks...
So what will it take to get a partner on board... hmmm, final bracelet-1 data perhaps?.. and they won't declare the Phase III trial setup before that. Data is not coming until Q4.. so realistically there are NO inflection points for 3 months or so...
Be prepared for the stock price to pretty much sit where it is for most of the year... that's why I'm practically out of this company. GLTA
Key patents expire in 2027, which means they cannot hope to get this approved before that happens... what a sad sh&% show this has been. No wonder Matty had a breakdown.