"If I were a biotech or big pharma, I'd be very concerned about the data and information that I have entrusted to the FDA. What will leak next?"
You are continously implying that the problem is/was at the FDA, YOU ARE WRONG !!!
IF FDA communications would have had leaked so easy...
...There would not have ever been a $71 per shareprice and MV of $5.5 billion...
...BECAUSE the (now known) persistent Fda criticisms and the pervasive Imcl inabilities to meet minimal trial design and execution goals would have twarted the HYPE...
...NO HYPE, NO MV, NO $71 stock, NO BMY deal...
PRECISELY that there was not leak AT ALL from Fda that Imcl was able to build up the big fantasious "blockbuster potential".
Look for leak at the most probable source, the ones who received the Fda Fax, not the ones who send it !!!
By the way, there are IRBs committes on each institution, hospital, clinic and even per large office practices that do clinical research in humans or animals, also for certain tissues like embryons, ova, sperm, cadavers, organs, certain blood (according to origin)some plants hybrids and/or genetic manipulations, release of altered species to the enviroment, and many more themes.
A trial like Erbitux even if done by Dr Saltz alone could have imply SloanKetering, NY/Cornell Hospital, Rockefeller University which usually tend to work alongside in many research projects, especially in the last 2-3 years that J. Levine became President of Rockefeller and improved the ties among the 3 institutions, so 3 IRBs minimun. (J. Levine is another Imcl board recently in controversy that cost him his Presidency and now is just a tenure professor, problems not related to Imcl).
Most probably trial done in many more centers and many more IRBs involved.
Actually, the protocol will not provide a lot of information, it is the collected data post protocol that will provide most important information, even more than the conclusions!
The data is to be saved for a minimun of 7 years or maybe more for BLA (common time frame in many institutions even for non clinical data) for internal and/or external party review, especially in controversial results. Remember Dr Baltimore Nobel Prize and Rockefeller President that had to get a full committe to review the immune cells citokines work of the Fellow (later proven not faulty) that cost him the Presidency and now He is in California. |
