Biotech Values

[ghmm]

What 2 months is that? Do you take issue with their report of making 98% of the padufa dates in 2014 (see below link)? (I don't track it, and it wouldn't surprise me if the success rate of hitting padufa bounced around some - but I know of now sustained trend)

The 2 months I was referring to are the 2 months ADDED by PDUFA V for both priority review and standard review. I don't understand how extending the review period speeds up the process but I can see how it would improve the success rate of meeting the decision by that PDUFA date .

BTW - do you have some suggested process change that doesn't substantively increase the chance of a bad drug getting on the market?

Obviously its a balance of risk/reward the authors are erring on avoiding risk while I would prefer they have more discretion to approve on partial data earlier. The authors were critical of subpart h approval because surrogates didn't always lead to clinically meaningful end points. Pointing out a few examples (I suspect there are many more cases of showing how subpart h has helped patients and the surrogate was shown to truely represent the progression of the disease). A better solution would be getting companies to complete their post marking commitments. Similarly I don't see why FDA can't be given the authority to approve a drug more rapidly with progressively less restrictive roll-out while more safety data is gathered.