RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Using the ATM or HC,
I was just talking with friend last night about ONC when ONC was still working with dogs.
And how I remember the very first Phase I trial report where ONC had just completed the very first single dose injection into humans in the first human tumour ever and took pictures of the tumour with a measuring device in the photo. Then a week later or what ever the time period was, ONC followed up with new photos that showed significant tumour reduction in the injected human tumour site, but for the first time ever also witnessed human tumour reduction in other tumours on the body, suggesting Reolysin (Named at that time) was travelling through the body to other cancer locations.
This was a single dose mono therapy, no other drugs or treatments involved, because tests were to check side effects and tollerance of Reolysin, and could not be sewed by other drugs or treatments.
So tumour reduction with a single dose of pelareorep, and at secondary tumour sites, with no other treatments involved.
That was when I first became a shareholder. Think that was around 1998. Who here remembers that?
Anyways, my point is I have been here forever... it has been hard, and a long haul.
There have been many times I felt we were close only to have scopes change and drag this out longer with lower and lower SP, reverse split, etc. it was hard to watch.
We came out of the standard Phase II trial around 2014-2016 and the FDA wrote a letter of 'Special Assessment Protocal' stating, hey, the results are so good we are going to allow you to move on to a Phase III trial and because the results are so good we are going to drop the patient requirement from 850 patients down to 450 patients, cutting tha trial requirements in half.
So at that time ONC could have started a Phase III trial, but....
The FDA also wrote a letter of favour basically stating to ONC, in review of the Phase II data, the FDA believes they see a bio-marker in the data, but the Phase II trial was not set up to capture that bio-marker data, so that data cannot be used. But as part of that letter, the FDA also stated, that if ONC can capture that data in a side arm trial and prove the bio-marker, the FDA will cut the Phase III patient requirements down from 450 patients down to 230 patients, cutting the patient requirements in half again.
I may not have those nunbers exact, but you get the idea.
Thus AWARE-1 was born. AWARE-1 results have been great, but ONC still has not openly confirmed the potentiial 2 bio-markers they found. Yes, not 1 but 2 biomarkers!
Through AWARE-1 BP was stating, yeah, this is all great, but what is the real Method of Action here. Thus BRACELET-1 was born to determine the Method of Action.
Sorry for the history lession, but you asked how much longer, and they only way I know how to settle that is with some history. How much longer... I have no idea... but there is very little left to do.
Roche started GOBLET and the ONC NR stated because they wanted to see if the same mBC potential bio-markers worked for gastro. And with the results that we recieved from GOBLET I think we have our answer. Not one patient didn't respond. Which tells me they blood screened for the bio-markers and thus had only patient in the trial that would respond. There is no other reason for every patient responding. They had to have used the bio-markers for every patient to respond.. so IMHo they work.
So there is little left to do. The next step is a Phase III registration trial.
And the results in GOBLET are so good, ONC should be able to cancel the rest of GOBLET and move on to a Phase II/III registration trial.
Gastro has moved ahead of mBC cause Pfizer needs 90 days to review after BRACELET-1 data is released exclusively to Pfizer. But these GOBLET result place serious pressure on that timing as we could be days, weeks, months away from an FDA approval for a Gastro Phase II/III registration trial.
Roche will be all over that IMHO.
I do not know timing on that, but with such good results, the FDA might not waste a lot of time reviewing, and I am hoping we see a Phase II/III approval prior to end of Q4 2022. That will be the game changer we are all waiting on.
Through the BRACELET-1 they now understand the Method of Action and started referring to pelareorep as a medical immuno molecule. But we will not know that until some time in Q2 2023, unless there is a buyout first.
The markets seems to be making the statement that they are not expecting anthing until possibly the major media event in H1 2023. Does that matter to me? Not really, cause everything is in place and will be resolved at the latest by end of H1 2023.
I honestly believe that GOBLET has changed all of that, and places heavy pressure on a Phase II/III trial, that I believe will even come from the FDA to get the Gastro Phase II/III registration trial under way as it is 3x better than the current standard of care.
So IMHO, you telling everyone you are out, and if you actaully do that, IMHO you are going to miss out on the pay day of a life time if you truly have 65k shares, which is just around the corner compared to my time spent with ONC.
It is really hard to watch this SP go down on such solid news. I am the same age as you, and payout on this potentially means retirement for me as well. I have been down for years... it seriously sucks!
Its your life and your money, but consider the summary of milestones that I have noted above that have been acomplished to date, and about to be released, other than emotions and personal retirement financing before you dump your shares.
I seriously doubt this will be another year. The longest I see this dragging out is end Q2 2023, but IMHO GOBLET just cut that in half as a minimum. Only time will tell.
I also feel that ONC now stating they want one BP for both Phases III trials also puts pressure on a buyout because of GOBLET. And I see buyout long before partnership.
Now I have stated this before, but both Pfizer and Mereck CEOs have stated in the past that they are looking to buy bolt on companies that are first in class, best in class and Phase III ready, as they want to run the Phase III trials they way they want to. With GOBLET ONC is all of that, 3x the current standard of care, with not only one, but two bio- markers, and not only one, but two Phase III registration studies.
IMHO a buyout is the only direction this will go, and GOBLET just sped up the timeline on all that.
Just friendly advice, as I have been here forever, but I am going hang on until they cash me out and dump a bunch of money in my bank acount.
Years ago, I decided to stop getting frustrated in the SP and only focus on the science. The science is there. The money will follow and soon. That is my best advice,
Now the legal...lol.
but there are always risks, it is the stock market after all, and you are responsible for your own investment decissions...I will not be responsible for any losses. Best of luckon what ever you decide to do. Cheers!