Copies of my posts expressing this same (similar) idea in my posts on Oct 31 and Nov 1, 2022:
hankmanhub
Re: Doc logic post# 526352
Monday, October 31, 2022 3:19:54 PM
Post#
526484
of 540456
I am no expert, but in my lay opinion, only one trial should be needed to gain approval for all solid tumors of any type.
Can we not ignore the differences between the cancer's location and focus on the similarities and design the trial such that say a minimum number of persons will be treated for each named cancer and above that minimum they could enroll any cancer type as may wish treatment to fill the trial. This could simply be thought of as a trial for treatment of "solid cancer," without any further adjectives or sub-categories.
So for example perhaps the trial could name say 20 (not rare) solid cancers, and perhaps have trial size of say 1000. Then they would have to enroll at least say 25 of each of these types of cancer in the trial. That would be 500 patients, and the remaining 500 could be of ANY solid cancer without respect to cancer type.
I would suggest that a good response to this sort of trial should merit a global approval for all solid cancers (even beyond the 20 named cancers) without taking years of trials, and huge expense, for many lengthy trials in every solid cancer type.
I am sure many will say this is not the way of the FDA. And I say why the heck not. If in fact certain cancers will not succumb to the DCVAX treatment that will be seen by following the treatment for the first several years to see if there is no effect on certain cancers. In any case even then at least the DCVAX is safe and does not cause any harm.
hankmanhub
Re: biosectinvestor post# 526487
Monday, October 31, 2022 3:38:22 PM
Post#
526500
of 540465
I understand where you are coming from. Sure there will be differences based on the organ in which the cancer finds itself and presumably there may be differences in what is required to treat them. But I suggest it is worth a shot that the similarities IN MOST solid cancers will allow them to be treated by the same PLATFORM without problem even if several may not (or may need some further modification to the same basic protocol). Say some 16 cancer types respond well to this treatment. Why delay approval for use in these 16 cancer types for many, many years?
In separate trial it may take many, many year, at huge cost, and those waiting with type X cancer, may have to wait for 10 to 20 years before we even get to trial for variety X cancer.. There would clearly need to be some sort of follow up procedures to determine which if any cancer types are not responding to this treatment and drop them from the label. But I believe that the greater good is for much more rapid approval and treatment for those cancers that respond well to the treatment (hopefully most solid cancer types)..
hankmanhub
Re: biosectinvestor post# 526590
Monday, October 31, 2022 10:28:18 PM
Post#
526607
of 540466
I have no quarrel with what you wrote. But just imagine if there was no aspirin and it just got invented today, This is a treatment that reduces high fever (among other things). If they now ran trials to put aspirin on the market as a treatment for high fever, would they have to run a separate trial for each indication wherein fever occurs - a very large number of possible causes of fever? Or simply run one large trial looking at fever as a single problem they wish to treat and disregards the differences that may exist for the purposes of this trial. I understand this a very imperfect analogy, but I think it crudely makes the point I wish to make - and not differentiate between a fever in a flu patient versus a fever in say a covid patient or any of the other multitude of causes of fever.
hankmanhub
Re: biosectinvestor post# 526628
Tuesday, November 01, 2022 9:21:40 AM
Post#
526669
of 540466
Of course there are differences, a major one is cost. I was making a point about the basic principle. Like I said, aspirin is a a very imperfect comparison. I was just using it to illustrate the basic point I was making.
AI
