Merck can get this vaccine approved with a blindfold, if there are long-term survivors. Regulatory agencies aren't going to approve on this data, but they'll be asking for more of the same. That's a logical, predefined slice that doesn't create a subgroup. Slides at the presentation will be highly "scrutinized".
25% and falling.
edit: I want to be clear about this. If you go to FDA with interesting results, they logically get interested. They're good scientists who want to help patients. The route with this vaccine is clear.
Cytotoxic T cells, as I've mentioned many times over the years, can eat their way into Fort Knox. These results are real, the questions are whether they're mediated by "adjuvant effects" (foremost including, chuckle, adjuvant) or by antigen sensitization, and, if occasional long-term survivors stand out, can the frequency be goosed by ipi or such? After Feuerstein and a few newsletter guys are done and the raid is finished? The presentation will, imo, get plenty of buzz. I added at 2.16 and 2.06. |
