Yes, I am sure it was ODAC. ODAC stands for Oncologic Drugs...

Yes, I am sure it was ODAC. ODAC stands for Oncologic Drugs Advisory Committee, but it sees any major New Drug Application, Biologic Licence Application or Pre-Market Approval (PMA) Application related to cancer products which fall in a reasonably wide grey zone, between clearly approvable and clearly not approvable.

As noted earlier in this thread, Redectane is an imaging agent. It is a radioactively labelled antibody. As such, it falls under the purview of the Centre for Devices (which includes diagnostics) and Radiological Health (CDRH). Because it is an injectable antibody, it would be reasonable for the investigator to include or exclude it in their analysis, in my opinion, as long as they were consistent, given the trials such products go through are so similar to those of a drug or biologic. There is a clear difference between drugs/biologics and imaging agents from a risk benefit poin of view. I state it as an example simply because with a vote in favour from ODAC of 16:0:1 (the one represents an abstention) it is the biggest example, I know of off the top of my head, where the FDA went against ODAC and rejected a product.

Whether or not Provenge is referenced in the JAMA article or not, doesn't really matter (I didn't even check). It was such a big event at the time, being the first cellular therapy and cancer vaccine to get that far, that there are a huge number of references easily found via Google. The references clearly explain both the panel vote and the issuance of a CRL. Moreover, the same is true for Provenge's eventual approval. It is the easiest of many examples to cite and for others to easily corroberate, that the JAMA article looked at ultimate approval, rather than approval on the first cycle. If they failed to include it in their study, they would need to be brain dead.

Personally, I thought the JAMA article was terrible and not worthy of JAMA. I couldn't find a reasonable hypothesis that was being tested, I found the methods wholly inadequate in terms of their explanation and the results fell in the same category, as a result of unclear methods. Even crap journal articles appear in good journals. The result they got is so clearly wrong, it would not surprise me if the investigators carefully excluded data to get the eyebrow raising they claim, simply to get such an esoteric topic covered in such a high quality journal.