Post by
fox7mf on Dec 03, 2022 9:48am
The pressure is on for Big Pharma...& Onc.
A few of us have touched on how the Goblet results, the buzz around Aware results & the FDA FTD have all combined to rachet up the pressure on PFE, Roche & others to get Pela & Onc wrapped up. All true. Onc, however, is not immune to the pressure to get a deal done. By deal done, I mean B/O. The huge importance of a timely purchase can't be underestimated. The value of Onc, at this time, might not get any higher. A partnership is ok, but wrinkles arise, problems come out of nowhere, and BP can end any partnership at the sign of the tiniest hiccup. If this were to happen, everyone is left in the cold. Right now is the most oppurtune moment to sell, make off like bandits, and let BP get this to cancer patients. My opinion.
Comment by
westcoast1000 on Dec 03, 2022 11:01am
Well said. I think the Goblet results and then the second Accelerated Approval made huge differences. Even if the Aware results are just about cell tumor environment, it is also meaningful in a huge, breakthrough way. We have the mechanism. And we have the biomarkers. Now is the right time.
Comment by
westcoast1000 on Dec 03, 2022 11:54pm
Worng, wrong, wrong! We do not have accelerated approval. We have fast track designation, as I summarized in posts a few days back. You would think I could remember what I wrote.
Comment by
jimsenior on Dec 04, 2022 7:02am
Interesting thought though. For the FDA Accelerated Approval Program a surrogate endpoint is required. I am assuming (perhaps incorrectly) that a biomarker might qualify. PDAC certainly has an unmet need. With GOBLET maturing, and signs that we have a biomarker, I do not see why asking for Accelerated Approval is not in the cards.
Comment by
jimsenior on Dec 04, 2022 7:39am
Now that I have been thinking about it. China's CDE (Center for Drug Evaluation) might be another avenue to explore. Tecentriq is approved in China for SCLC. After the posters on Tuesday, they might be able to apply for breakthrough therapy in China for both mBC & PDAC. Yes, idle Sunday morning speculation, but the mind boggles when one thinks about the potential market.
Comment by
itntdf on Dec 04, 2022 10:16am
remember that oncy sold exclusive rights to pela to adlai nortye which covers china, hong kong, macau, singapore, south korea and taiwan. oncy WILL be entitled to double digit royalty payments if/when AD commercializes pela in any of those markets.