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Replies to #68783 on Biotech Values
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MRX22

11/20/08 11:54 AM

#68788 RE: north40000 #68783


"What is wrong with it?"

The company has $24M in cash and will not be able to complete the PACT trial or better yet survive without a partner -
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friendofthedevil

11/20/08 12:06 PM

#68789 RE: north40000 #68783

The problem with it is that it smacks of data mining. We had been discussing moving the median survival upwards with TNFerade. All other trials we were comparing the current SOC with were discussed in terms of median survival. No other drug combination was discussed in any other terms. I have look at dozens of trials and I don't remember one discussion that didn't center around median survival.

Can anyone name a drug that was approved by FDA that didn't increase median survival AND didn't increase cure rate?

So, how important is that hazard ratio - if it were to hold until the end of the trial? (big if)
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DewDiligence

11/20/08 12:31 PM

#68792 RE: north40000 #68783

>GNVC– I found this analysis interesting and persuasive.<

I’m surprised you did. The analysis, such as it is, strikes me as hoping and handwaving.

>It is unfortunate that many seemed to have looked only at median survival and panicked…<

As I noted in the reply to fotd, the median number is not especially meaningful. However…

>…when it is obvious from the data that the real benefit of TNFerade comes in the 12-18 month period.<

It is not at all obvious that TNFerade produces a bona fide medical benefit that is experienced in the 12-18 month window. It is more plausible, IMO, that the observed benefit seen during this window is a fluke.