RE:RE:Single Licensing Deal ?I totally agree with you as to a partnership or buyout prior to the release of Bracelet data.
With these latest gastro results with more data to come between now and the KOL on Nov 14th, and the fact that Golblet is fully enrolled, and the fact that ONC is talking with the FDA regarding dropping the Goblet trial and moving directly into a Phase II/III gastro pivital registration trial puts a serious amount of timing pressure on any partnership or buyout deal, as we could be DAYS/WEEKS away from the FDA stating ONC is a go on the Phase II/III gastro registration trial.
I am fully expecting/hoping ONC will spill the beans on the FDA Gastro approval side on Nov 14th, because, IMHO I believe ONC and ROCHE already know the FDA will allow them to move directly into a Phase II/III registration trial for gastro, based on this last data and what is to come by Nov 14th, as they are all working with real time data, and I fully expect that those preliminary discussions have already occured wuth the FDA. I don't think any of the three there have their heads in the sand on this one. I think they all already know.
IMHO that again puts ROCHE in a better position than Pfizer. As Pfizer is still waiting on the final Bracelet Data package to start their 90 day exclusivity period. Pfizer has the real time data from the trial, but not the final data package that I don't think is actually due for release until some time in late Q4 2022 or early Q1 2023.
Does Pfizer currently know what they need to know to make a rushed bid ?????
ROCHE knows exactly what pelereorep does with Tecentriq for mBC.
Tecentriq is 66% of ROCHE's revenue and pelareorep makes it work better.
ROCHE knows exactly what pelareorep does with Atezolizumab for Gastro.
ROCHE just bought a company for $1.2B that makes pelareorep work better.
The FDA could in DAYS/WEEKS, state ONC is a go for the Phase II/III gastro registration trial.
I like the REPLY comments regarding the thought that ONC stating licencing one BP for both trials might be an indication and sending a message that ONC wants a clean out. That would make sense to me.
That would tend to coincide with my opinion of why CAR T has not had a deal yet, as I believe BP said don't sign any more agreements, or you will de-value any buyout.
It does not make sense to me that any BP would want to be a Licencee for someone else's drug of this potential magnitude. Why just sit and watch and risk someone else stepping up to buy ONC out from under them, and miss out on a multi billion dollar per year product opportunity.
It makes even less sence to me for Pfizer to be involved in the Gastro side. I like ROCHE for a buyout.
Because of this latest data release, IMHO Pfizer might be too rushed on the mBC and are not in the know for the gastro side. Possibly too much catch up there to complete in a short time period to rush a bid.
With this latest gastro data, IMHO, ONC is potentially DAYS/WEEKS away from the FDA stating the Phase II/III Gastro registration trial is a go... but who knows these days.
But, if that occurs...
IMHO I would expect to see a partnership or more so a buyout before year end 2022 so they can get on with the PhaseII/III gastro registration trial.
IMHO the KOL is going to be huge. ONC has stated that they will have Key Opinion Leaders from the imedical fields there and will be discussing the immediate need for these treatments. Wouldn't it be nice to have FDA aproval for Nov 14th.
IMHO I think it is a possibility. if not, it will be very shortly after.
Cheers!