Post by
venture009 on Jun 05, 2023 12:53pm
KOL
This boards consensus is the information was positive, only wish the market and the FDA shared the same opinion. Without FDA granting AA ,and why wouldn't they, with such a difficult disease to treat and few options available, or the announcement of a partner or buyout the response will continue to be muted. This has been the storyline of this company for so many years beginning with the head and neck back in 2008. They just can't get any traction to see the share price rise to the levels required to garner any instutional investor interest or a BP and one wonders why when this boards response is so overwhelmingly positive. Let's hope they are negotiating with more than one BP otherwise the prospects of a happy ending are growing even more remote. No money to conduct a PIII themselves leaves very few options. This is the reality and they better move quick, time is money.
Comment by
Angler101 on Jun 05, 2023 8:11pm
Yawn......I see....so you and your wife decided the best plan was to soft bash the message boards to try to discourage investors.......sure bud....whatever you say
Comment by
Normandt on Jun 05, 2023 10:03pm
009 is mentally retarded, don't bother with him. he is in the same team as armedesliar and ubertheclown. Just read the yahoo forum to get an idea of the level of their understanding.
Comment by
Lesalpes29 on Jun 06, 2023 8:13am
Yes Normandt this Venture009 is a FALSE INVESTOR DIRECT FROM YAHOO BORAD! Please we have to stop to talk to him and Bucky!
Comment by
Quentin30 on Jun 05, 2023 1:56pm
why wouldn't they. grant AA Venture ?? WEll they need evidence of a surrogate end-point biomarker... I'm hoping that the increased PFS will act as a surrogate for increased OS, thereby allowing ONCY to go for approval on the basis of PFS. but the data needs to mature for that to happen, otherwise, they will need OS as end point, which will take 3-4 years... :-(
Comment by
Noteable on Jun 05, 2023 2:29pm
"They" meaning ONCY's Big Pharma acquirer. That's who the 'they" is in this picture.
Comment by
Noteable on Jun 05, 2023 2:35pm
and what in the world is a surrogate endpoint biomarker?
Comment by
Noteable on Jun 05, 2023 2:43pm
The surrogate endpoints of ORR and PFS have been defined as biomarkers intended to substitute for a clinical endpoint. So ONCY has already defined the biomarkers and have reached them in the Phase 2 Bracelet-1 study. A Phase 3 will receive an Accelerated Approval based on the PFS surrogate endpoint which Big Pharma would be responsible in achieving, followed by OS.
Comment by
Quentin30 on Jun 05, 2023 2:58pm
If OS is the end point, ONCY needs solid data to correlate PFS as a surrogate for that... So until they have that correlation, there will be no accelerated approval. thanks for clarifying Noteable... I wonder why the market still seems unimpressed, when you are as happy as a pig in truffle t urds. :-) to da moon... KOL, more like LOL
Comment by
Azzak34 on Jun 05, 2023 3:01pm
Haha you are clueless Quento!
Comment by
Noteable on Jun 05, 2023 3:18pm
PFS is correlation enough given the FDA's Accelerated Approval guidelines. Quentin30 it seems that you can't quite keep up.
Comment by
Azzak34 on Jun 05, 2023 2:45pm
Haha you really tried to sound like you know stuff, but you don't!
Comment by
YegJeeber on Jun 05, 2023 10:58pm
Amazing how you can throw sox any words together and not formulate one logical or rational thought. SMFH