RE:It is frustrating...I have been giving some thought to this 90 day registration application period and the 30 day FDA approval process.... I was not aware of this time frame previously.
and in relation to your comment above about Noteable stating BP likes to wrap up deal before year end. That would make good tax sense in a high profit year. Re-allocate some of the years profit to avoid taxes.
And, something else that struck me a very odd.
The odd: On October 5th, 2022, ONC issued a NR that stated we would be seeing two posters.
Poster 650 for the GSTRO
Pelareorep combined with atezolizumab and chemotherapy demonstrates encouraging results as first-line treatment in advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Interim results from the GOBLET study
and
Poster 548 for the mBC and AWARE-1
The oncolytic virus pelareorep in combination with immune checkpoint inhibitor activates T-cell functioning in early breast cancer patients – immunophenotype results from AWARE-1 study
The ONC NR on Nov 7th, 2022 announced Poster 650, but we never got poster 548 for AWARE-1.
AWARE-1 was never released/discussed, and the only note I found regarding was on the milestones list that AWARE-1 final data was simply stated as due Q4 2022. Why the change ?
Was the data just not complete? IMHO AWARE-1 was complete a long time ago so there should be no reason for the data to be incomplete. They even registered a poster for the event so what happened?
I also think back to the CEOs of Pfizer and Mereck stating the are looking to buy first in class and best in class companies that are Phase III ready, so they can run the Phase III trials the way they want.
So, that raises the question in my mind... Will ONC actually be making that Phase III application, or is that something that the BP is going to want to do. This is only pure speculation, but IMHO I would think BP would be wanting to make that application themselves to have more stakes is what is actually to be required in the Phase III trail and how the Phase III is controlled. Because that is pretty much what BP stated above (in blue).
It does not makes sense to me to to have ONC make application and mess something up for the way BP wants to run the trial. So, in consideration of that, I have to question if ONC will actually be the organization making application, or if BP will say hold off we want to do that?
Now the reason we have not had anything on the AWARE-1 is that data is all confidential between ONC and ROCHE, and Roche has the final say there to release.
Again, pure speculation, but raises the question in my mind, maybe Roche does not want that data released publicly. It seemed poster 548 was all ready to go, but maybe ONC got their hands slapped by Roche stating do not release/discuss AWARE-1.
It just seems really strange to me that they were a go, and then stopped with no explanation.
Totally speculation again, but maybe Roche slapped their hands again regarding GOBLET discussions, because the KOL seem so down played compared to earlier comments of "In my opinion pelareorep could transform the standard of care!
I was expecting to have a more grandious discussion at the KOL and be a bigger day/week following than the related NR the Friday before, but the KOL turned out to be a total snoozer. Why all of a sudden so toned down?
I am self employed and I think about business operations all the time. And if it was me looking to buy ONC, I would not want ONC releasing all the highly valuable and confidential date weeks, months before I bought them up.
So, in my mind I question if AWARE-1 will every be released?
Again this is all total speculation on my part, and just things I ponder. And, I do not know what the timing on a buyout will be. BP may want Phase III approvals in place before a buyout, which would mean at least March 2023 before a buyout, or maybe BP wants to make those applcation/negotians themselves. If it was me, I would want to complete the application/negotion process myself.
If BP wants to make application themselves, then there is really nothing left to do, other than make a bid and get moving forward.
Not sure what to think, but I am personally hoping for a buyout before the end of the year (I am sure we all are) and finally get the heck out of this stock after 24 years and have a Merry Merry Christmas.. LOL, but this application process for Phase III raises a lot of 'who will', and timing questions in my mind.
Could go either way...
Either way... I will wait.
Cheers!