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To: Elmer who wrote (2185)	12/13/2000 5:40:47 PM
From: scaram(o)uche	Respond to of 4974

emails that I sent to a group of friends, 6/3....... Subject: Re: MAXM;s Melanoma Phase III Resent-Date: Sat, 3 Jun 2000 15:04:41 -0700 Resent-From: Date: Sat, 03 Jun 2000 15:00:47 -0700 From: Richard Harmon Organization: > Treatment with Maxamine and IL-2 improved overall survival, increased > survival rates at 12, 18 and 24 months, and improved > time-to-disease-progression over treatment with IL-2 alone. As previously > reported, improvement in survival was statistically > significant in patients having metastases of their melanoma to the liver, a > patient population that historically has had a very poor > prognosis, and in all subgroups analyzed under the approved statistical > plan. I find this terminology to be fascinating. It's either point blank a given and the drug WILL be approved, or the regulatory group at Maxim will be forever cast out. We can all agree, I hope, on this statement. On an intent to treat basis, the data looked pretty bad. On an intent to treat basis, the trial failed. Does anyone object to that statement? Can we call it fact? Subject: Re: MAXM;s Melanoma Phase III Resent-Date: Sat, 3 Jun 2000 15:15:44 -0700 Resent-From: Date: Sat, 03 Jun 2000 15:11:53 -0700 From: Richard Harmon Organization: > As previously > reported, improvement in survival was statistically > significant in patients having metastases of their melanoma to the liver, a > patient population that historically has had a very poor > prognosis We can all agree that this is post-study subset analysis? How many subsets were analyzed? Were the statistics corrected for such? Is it true that, due to flushing, this trial was impossible to blind? The patients knew if they were getting histamine or not? The physicians (in addition to the pharmacists) knew which patients were receiving histamine? How did the liver met data look, Pittsburgh versus the rest of the world? (this is not a trick question.... I don't know the answer yet) [to be continued, gotta go get kids]

To: Elmer who wrote (2185)	12/13/2000 6:40:24 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 4974

(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.

To: Elmer who wrote (2185)	12/13/2000 7:06:54 PM
From: scaram(o)uche	Read Replies (2) \| Respond to of 4974

David: Are the FDA filings open to the public for review prior to the advisory board meeting? The company submissions? No. If you're talking about the FDA's review of the submission and/or questions for the panel to consider...... yes, it's a new rule. Read about it recently in (?) BioCentury, but don't remember specifics. So, how is it that the Street knows knows the data stinks and the analysts don't? You can see that I don't like the company, and that I didn't accept what they were saying as being truthful. If you've been around the sector long enough, you get to know the people. Toth is good, but he's relatively new. Mike King hired him when King was at Vector. No excuse for Berger? telling me that a lot of people knew the data was manipulated. Wouldn't surprise me at all. Even with my negative sentiment, I didn't have the guts to short into the face of their claims and data. The sector once again fails to police itself. The good companies are tainted by liars, cheats and/or incompetence (one can say, it the case of MAXM, that incompetence is in play at very least). We need a "Good Housekeeping Seal of Approval". Rick