The Difficult Transition Into Phase 3

Preclinical and early clinical development is expensive enough already for VC companies but it gets really expensive in Phase 3.  Hence, not surprisingly, few small companies tackle Phase 3 programs on their own.  Unless an ‘angel investor’ with deep pockets Continue reading The Difficult Transition Into Phase 3

The War about Data Access

Several articles in the April 7 issue of BMJ were devoted to the epic battle fought by BMJ and Cochrane to gain unfettered access to the Tamiflu® and Relenza® data. Not just some data, but all the data. Considering that Continue reading The War about Data Access

FDA Adboard on Tedizolid – Why?

FDA’s Advisory Board session for tedizolid (3/31/2014) was a foregone affair:  Looking at the reviewer’s slides, there was really no question about the drug’s efficacy.  Did tedizolid cure as many patients as linezolid?  Yes, it did.  Did the sponsor follow Continue reading FDA Adboard on Tedizolid – Why?