(continued)
Subject: Re: MAXM;s Melanoma Phase III
Resent-Date: Sat, 3 Jun 2000 15:28:56 -0700
Resent-From:
Date: Sat, 03 Jun 2000 15:25:07 -0700
From: Richard Harmon
Organization:
other companies have made claims about what FDA said was OK to do, that FDA had given permission for a given analysis before the trial began.
DEPO, for instance.
Would the MAXM bulls please do their best to tell us why FDA will not look most intensely at the intent to treat data? Why can't other companies expect this sort of deal?
That is..... why would FDA agree to this sort of arrangement? What was special about the protocol and/or histamine?
(snip)
it's not as if I have a vested (ego perhaps, but not
financial.......... :-) interest in negative sentiment.
I've looked for any description of the detailed professional
background of the regulatory personnel at MAXM. I can't find any, as they're not senior officers. Are they good?
Subject: Re: MAXM;s Melanoma Phase III
Resent-Date: Sat, 3 Jun 2000 15:43:33 -0700
Resent-From:
Date: Sat, 03 Jun 2000 15:39:43 -0700
From: Richard Harmon
Organization:
OK.... back to mechanism......
When they talk to the press, they still mention T cells. We know how T cells kill, and we know the receptor that they use to recognize antigen.
First, even if there was an antigen to recognize, how would they go to a tumor because of histamine?
TILs..... has anybody ever convincingly demonstrated that they have tumor-specific activity?
BCG trials for melanoma...... was there ever ANY reproducible effects on metastatic lesions when potent immune reponses were induced at a primary site. Etc., etc., etc.
OK, switching to NK cells..... the mechanism of killing action is less well defined. Agreed?
Even then, the proposed mechanism that is currently in favor is near and dear to my heart, and it **is** compatible with the mechanism of action for histamine as proposed by Maxim..... that is, if NK cells destroy tumor cells due to a sub-optimal expression of MHC, then monocyte inactivation of NK cells at a tumor site would be bad.
See, I *said* that it would get better for MAXM bulls.
How do the NK cells get to the tumor? We've discussed this..... OK, they don't.... we now know that they just sit there, passively, in the liver, and let the tumor cells come to them. We finally have an answer!!!!
:-)
Lotsa monocytes in livers.
Come on, bulls, defend this piece of (edited) company!! I agree, it looks like they have something here that will be useful for certain clinical situations. How will FDA like them?
Subject: Re: MAXM;s Melanoma Phase III
Resent-Date: Sat, 3 Jun 2000 15:49:30 -0700
Resent-From:
Date: Sat, 03 Jun 2000 15:45:39 -0700
From: Richard Harmon
Organization:
I've asked for Pittsburgh versus the rest of the world.
Hope it looks good.
Now..... the trial, on an intent to treat basis, failed.
For those patients who did not complete the protocol, what did the data look like?
This is not a loaded question..... I don't know the answer. I do know that, regardless of promises made or not made, FDA will look at the data. |
