RE:RE:RE:RE:RE:RE:Recent CMO promotion/ announcement ...(i.e. to see if the data was in-line with expectations...
Yes, totally! I don't just pull this out of my under wear... lol
I among others have been reading and listening to ONC for years. 1998... yikes !
I also recall comments about Big Pharma due-diligence around end of 2020.
We need to remember that ONC has a completed a sucessful Phase II trial, and ONC could have started the Phase III trial immediately following that. Finances aside. ONC recieved a letter of special protocal for the Phase III trial reducing the trial from 800-850 patients down to 400-450 patients.
But, as discussed in Conference Calls and Fire Side Chats and BNN chats, ONC, the FDA and Big Pharma were consideing these biomarkers that they thought they were seeing, so AWARE-1 was created to confirm the biomarkers. That all went very well with lots of comments that the results were statistically significant.
The comments per AWARE-1 from the FDA was that if ONC can confirm a biomarker the FDA would reduce the Phase III trial from 400-450 patients to 200-250 patients. That is significant. But the FDA's response to the biomarker data has not been released to date.
ONC has suggested they have 2 biomarkers that they were confirming for MB. Now trying to confirm similar biomarkers for Gastro in GOBLET.
Then I also recall ONC stating, that Big Pharma (potiential partners, not necessarily the FDA this time), were asking something to the effect of, while all the AWARE-1 data is promising, pela also appears to be doing 'this', can we confirm that pela is doing 'this', and thus Bracelet-1 was developed. (Just leaving the technical out to simplify this)
I am not sure, but I thought this might even be additional biomarker or indicator confirmation. It was my understanding, that Big Pharma wanted confirmation of these additional indicators before partnering (or buyout out IMHO). Not the FDA. I do not believe it is survival data that Big Pharma are waiting on, that some seem to be suggesting.
So IMHO it is my understanding that the Bracelet-1 was driven by potential partners (or IMHO potential buyers.) wanting to know additional indicator data before engaging. The last step so to speak. Not a requirement of the FDA. I do not believe Bracelet-1 was officially a requirement for the Phase III registration trial by the FDA.
It seemed to me at the time, that ONC also illuded to that, as Big Pharma would eventually buy ONC, Big Pharma wanted to firm up these last question before engaging and thus Bracelet-1 was created.
We are in the middle of Bracelet-1 right now, nearing completion of enrollment, and ONC, the FDA and the Big Pharma collaborators are all getting real time 'live data' from Bracelet-1.
IMHO, if I was buying ONC, there would be gag orders to not release data, and as soon as the data I was looking for in Bracelet-1 was significantly proven, so not necessary to complete the trail, that would be the time I would pull the trigger and buy up ONC, before all the data is publicly released. Keeping eveything in house.
IMHO, we are there right now!
I see absolutely NO benefit for Big Pharma to allow ONC to release a bunch of corporate data just before Big Pharma buys up ONC! That would be corporately silly. Thus IMHO gag orders are in place. That's why limited NRs.
... until the big NR.... the 'buyout'.
Here's hoping!
I really don't see a partnership deal happening based on what has beening going on.
I will be shocked if it is a partnership.
Good luck all!