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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: keokalani'nui who wrote (2291)12/12/2000 11:30:42 PM
From: Biomaven  Respond to of 52153
 
Wilder,

First, I dodged a (small) bullet on this one not because of any brilliant analysis that I did figuring out that their data was no good. Rather, I encountered enough people who were uncomfortable with the drug and trial that I thought the risk/reward wasn't there.

On the toxicities, I haven't yet read the medical review. I would have thought that most (if not all) of the severe tox would have come from the IL-2, not the maxamine. They were using a big IL-2 dose, and so toxicities were to be expected.

Peter



To: keokalani'nui who wrote (2291)12/12/2000 11:47:05 PM
From: Spekulatius  Respond to of 52153
 
Wilder, I have scanned through the statistical evaluation of the Maxamine application. I have only a basic knowledge about statistics but its clear to me that Maxim has bend the statistics to get more favorable results:

1) The evaluation of the subgroup was not intended and communicated with the FDA before the trial was started. MAXM "discovered" a statistical, subgroup (with liver tumours ) only during the trial. This however is flawed, since many subgroups could be constructed and there is a high chance of finding a statistical significant result in one of the many subgroups just by chance.
2) While the whole patient population appear to be sufficiently randomized, the Liver tumour" subgroup itself was not, which makes a statistical significant result for this subgroup very questionable.

3) That said,i don't think that MAXM can "prove" with the results of this study that Maxamine works it also doesn't prove that it doesn't work). I do not believe that the FDA will approve Maxamine for anything based on this study.

4) MAXM will have to start a new trial, to get Maxamine approved for Melanoma. I do not think, that data from this "flawed" trial can be augmented with new data to get Maxamine approved.

5) MAXM might be a good speculation if the stock falls close to cash value. They should have a reasonable chance to get Maxamine approved for Hepatitis C and this would be a real blockbuster. Hopefully, the result of this trial will be more favorable....