RE:Patient Protocol Questions I have a very low expectation that biotech execs tell investor the WHOLE truth and the less palatable stuff only comes out when forced. I can't put everything together that's been said in the past and now a make it work without some bending of the truth. I could lay out a few scenarios but they all have a deal of cynicism in them. It could be that the FDA has signalled all along slow progress and so the earlier indications of thing progressing faster just ignored that fact. I don't necessarily think things always take long. I think biotech guys just don't like to lay down the bare truth at the start of something that has a long timeline, they give us the absolute best possible scenario, which was never the likeliest outcome, and then deal with the adjustments as things come along.
When you look at that protocol if we are only at patient 7 then the bulk of part 1 patients are still ahead of us. That would suggest this bleed well into Q1 22. We are probably at the point where you might have expected the first sign of efficacy. It might still happen soon. So maybe they thought they could have delivered the news they really need by end of year and it wouldn't matter so much they were still recruiting in part 1.
I think given the sparse data they've shared nothing look obviously negative. If they want a more positive reading of the cancer program they are going to need to disclose more.
SPCEO1 wrote: Sorry for the tests - just trying to sort out the copying an image issue using the technique wino suggested.
So, since the first patient died, let's assume the others have lived just for argument's sake. Since we know we have advanced to the 420 level, does that mean that only one patient has recieved drug at the 300 level or did all of the 4 assumed remaining patients advance to the 300 level? If only one patient got a dosage at the 300 level, is that good enough for the FDA? I would think they would want multiple patients to have shown no toxicity at that level before establishing it as the MTD.
Why did TH use the rpevious slides of this variety that were clearly not what was going on? And how could it take this long to dose just 6 patients overall? Should we be concerned about the seemingly very slow pace of the trial? I am continuously amazed at how drug companies always massively underestimate the time period for a trial to be completed.
Do they have to get to at least 15 patients for the trial to end?