Biotech Values

[gofishmarko]

Re: DNDN skepticism

I tend to agree with your analysis of DNDN's actions and timing of same. I also think the 'key question' is the one you outline here :

>> Thus, the key question is whether 9902a is sufficiently supportive of 9901 to warrant approval based on one successful study and one supportive study. My contention is that 9902a is not supportive because the raw p-value for overall survival was 0.33 and the Cox analysis that lowered the p-value to 0.02 was not fully pre-specified. <<

What I wonder about is the extent to which the FDA will deviate from stringent requirements , e.g. , that a particular type of analysis be prespecified , in indications where survival is measured in months with the best available treatments. I would hope that they maintain some flexibility in these cases particularly , though not so much as to allow bad science to prevail. My own guess, like yours ,is that they'll get the approvable letter pending 9902b , but I think DNDN is still a reasonable buy at these levels if you have a medium term investment horizon , and you could get an early surprise.

Here's a question that bugs me. Why the crossover trials ? Was this all DNDN's idea , or the FDA , or both ? Was it done for compassionate reasons , or to encourage enrollment ?

If they had run clean trials , i.e , Provenge plus SOC vs. placebo plus SOC , the analysis would have been straigtforward and the results clear by now.