PP this summer after major media event???? I am not sure what to think now.
Matt has stated in the past that they financially need to have a partnership to go into Phase III,registration studies.
Matt just recently stated in a January podcast, that he hopes to be into Phase three in H2 2023. That would tend to suggest that ONC needs to have a partnership or buyout 4-6 months prior to starting Phase III, as it simply takes time to organize the Phase III trial prior to start.
However, in the latest AGM webcast, ONC is now stating the data is still maturing and will do so out into 2024, as the patients are all living longer, which the longer they live the better the data, and puts ONC in a stronger position for a better BP deal, and that ONC does not want to jump into a deal now, as they may miss out on something bigger, once the data set is complete in 2024. At least that is my take on what was said.
So it would seem these two comments now contradict each other.
With respect to Accelerated Approval or Priority Review, I was thinking we could see AA on Panc any day now, but I now question if they are letting the data mature for final determination of the Panc registration study parameters as well. I would have thought the panc 33% better than the current standard of care would be enough for AA in a Phase III registration trial pretty much immediately.
Roche is needed for the Panc Phase III. ONC wants one BP for both trials.
ONC is now also talking about a 15 patient Panc Phase II expanded scope trial. I know Matt previously state they were done with Phase II panc as previously run and were looking forward to a Phase II/III pivotal registration trial. So, I can only assume this Phase II is part of that PhaseII/III registration study. Sounds like this Phase II includes more than just Roche’s drug.
So, are we really looking at a partnership/buyout within the next 4 months, or is it now truly a 2024 thing, or is it just smoke and mirrors on ONC’s side to let BP know that ONC is not eager to simply accept a low bid, thus making BP reconsider larger bids.
Is this just business tactics….
Is this advice from our two BOD corporate buyout guys ?
I find this AGM webcast raises more questions for me than answers.
Now the following is totally wild thoughts/speculation…
I remember a few years back on the yahoo chat, one user stated that ONC was considering a PP at $98. It was only trading around $3, so that was simply not going to happen. But I always wondered where those comments come from and if there is any deeper truth to them. My thought at the time was, well, maybe ONC felt they had good enough data to release that would increase the SP to roughly $100 SP and at that time, then they would do a PP at $98 and finance the Phase III trial and go it alone. Again, just some thoughts, no truth to that, just my consideration around that rumour on Yahoo.
The only reason I bring this up, is that I find myself thinking something similar again. ONC has run out cash until mid 2024 now. But that is not ample cash to fund the start of, and run the two Phase III registrations studies for mBC and Panc in H2 2023.
So, I don’t know how ONC plans to finance this, without a deal until 2024, if they still expect to be into Phase II/III registration studies in H2 2023, and I have to question the basis of this old rumour again in ONC’s position today.
Does ONC feel they have compelling enough data to release at the major media even this summer, to significantly increase the SP to say…. $100 SP and then do a PP at say around $98 to fund the Phase III registration studies, moving trials forward, gaining hand on BP, until BP decides to step up ????, all gaining value for ONC share holders?, but also diluting us longs.
All I am thinking is that, if ONC is not going to consider offers until the complete data set in 2024, how the heck are they going to fund the Phase III registration trials in H2 2023?
And this question has me considering that ONC’s major media event could be followed by PP at a much higher SP. At what price, I have no idea,but am starting to think this might be a consideration at ONC for interim funding.
This would satisfy both H2 2023 registration studies and holding out for end data points for better BP offers in 2024.
Otherwise the two comments
- start Registrations studies in H2 2023
- And wait on better BP offer until data end point in 2024
are in contradiction and not financially possible IMO.
I don’t know how these comments make sense otherwise.
Again, only total speculation…
We will only know more as it happens, but I am now thinking there will be a PP after the major media event, if BP does not come up with an acceptable offer.
I really don’t want this. I want a buyout by July…. I just find myself thinking about this….
Anyone have any thoughts as to how else they might fund the registration trails?