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Replies to #49956 on Biotech Values
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p3analyze

07/20/07 6:09 PM

#49957 RE: DewDiligence #49956

Nice break down - however I am confused by your partition of probabilities.

Regarding Senario 1 -FDA ask whether should wait for OS. I think this senario is highly unlikely because FDA almost always ask 2 questions ie whether it is effective or whether it is safe.

Any rate, the sum of probabilities (conditional or marginal) should be 1 regardless of which senario is played out.

Under senario 1 - your 1a and 1b together amounts to 104% (16%+88%) >100%? under senario 2- your 2a and 2b added up to only 76%, this is OK, if there is a third outcome which you did not list which should sum up to 100%?


Howeer, your 1a, 1b, 2a and 2b did sum to 1 which is good, using the numbers you provided, one can figure out the conditional probs and marginal probs for 1 and 2 as follows:
You handicaped a 74% probability for 1), and under 1, your conditional prob should be 0.65 for 1a, and 0.35 for 1b.

Then you handicaped a 26% probability for 2), and under 2, your conditional probs should be 0.73 vs 0.27, for 2a and 2b respectively.

If I were correct in saying that senario 1) has 0 probability, then the accelerated approval probability would be 73%.
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Jonathan Robinson

07/21/07 12:01 AM

#49970 RE: DewDiligence #49956

Apparently the main issue folks are having with GPCB and SPPI here relates to issue with PFS measure and inclusion for first time of initial OS data - and with the P value in the 30% area, some folks are concerned with what it is going to say. The company did have the subset analysis for 12-monthers (supposed to mimic curve better (at 8% for low-powered subset).

Jon
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Jonathan Robinson

07/21/07 1:21 AM

#49976 RE: DewDiligence #49956

My odds are as follows:

OS is focus of questioning and discussion: 1/2
Let's wait for data: 60%
Not wait: 40%

Not focus: 1/2
PFS compelling: 75%
PFS not compelling: 25%

This gives case odds of: 1a 30% 1b 20% 2a 37.5% 2b 12.5%
Odds of approval are: 1a 20% 1b 70% 2a 80% 2b 5%

Overall odds: 51% (did not game this either)

Jon
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DewDiligence

07/22/07 3:52 PM

#50046 RE: DewDiligence #49956

Handicapping the Satraplatin ODAC:

Anyone is welcome to respond to #msg-21433622. Jonathan Robinson and p3analyze have chimed in with thoughtful replies.
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iwfal

07/22/07 4:37 PM

#50052 RE: DewDiligence #49956

Satraplatin - If the survival data are the focal point of the ODAC then I would guess the submitters are going to have problem - because the survival data appear to be trending to an HR that would not be stat sig.

Note that I haven't done any detailed analyses and know very little about the trial history of this drug - so I am not competent to speak to the general review. I am instead only making a micro observation - extrapolating from the fact that the current p value is about 0.3 and more than 1/2 of the deaths have occurred.

Clark