RE: PLD Approval & Why It Sets a Precedent for AVA600013 Feb 2025 12:02
D, I'm not sure why the FDA have not already approved it. Why submit it in the first place on P1a data if it was always going to be dependent on P1b results?
It might just be me (it normally is here), but I seem to be the only one that expected when P1a completed in Q2 2024, that P1b dosing would start soon after (end of Q3 at the latest) and that we would be getting the results by the end of Q1 2025.
I don't know why it seems not to have started. was everybody else expecting a 9 month hiatus?
My best guess is there were, right from the very beginning, some unexpected results from patient to patient causing the extra cohorts and 2wd regime to try and better understand the vagaries of the results.
The safety part does seem to be have been completed successfully and has been often highlighted, just making dox more tolerable should be enough, and yet it seems that is not the case. Which then to me, infers, dox does not universally behave in the same way as expected when delivered straight to the tumour. It may be in some cases it is less effective?
So i think everything, absolutely everything, hinges on P1b now and as a result there is still ongoing deliberation on what to dose and to who. AVCT obviously, want to make this next part of the trial as successful as possible and I imagine are cherry picking as much as they can, the most ideal candidates to ensure that the results will be as uniform and as good as possible.
To me all this underlines the premature exercise of trying to value AVCT.
Something is not going quite to plan and in fact never has done (or at least it has never gone to the plan we were told from the BoD as shareholders)
It also strikes me that the DX companies may have been bought at a big premium, as vehicles to quickly get that AVCT DX tech to market, but if the AVCT tech is also not performing to expectation, it might be a reason as to why the amount paid by AVCT was too much and why maybe, it seems to be hard to sell the companies on at a price that won't further harm the SP? (I am making a lot of guesses there clearly, but again I am just trying to figure out why nothing AVCT does seems to benefit shareholders.)
If my guess is near the truth it might be why BP is waiting for proof of efficacy in the trial before any sort of commitment, given the failure thus far of any commercial success in any other area.