Sorry for jumping in here.
You ask:
>>my question regarding CLSN is this----doesn't the FDA need to receive a NDA from Celsion before they will know what the results of the Phase III trial are-----and if the results show that for a specific subset of patients the PFS and OS exceed the goals set by the FDA in this study----wouldn't the FDA, given that doxorubicin is already approved---and we are talking about HCC----be justified in acting on that data.
So really 2 questions - 1) Does the FDA need an NDA and 2) Can it justify an approval based on a subset analysis?
1) Yes, an NDA would be needed for the FDA to take any action.
2) IMO no way. We had an SPA based on the entire HEAT trial and the second you try to justify approval based off only a portion of that trial, you are no longer under the SPA.
Now, companies do not NEED an SPA to get approval, but without it, you typically want two well-run ph3 trials with both being stat-sig. We have ONE, that failed (MT: "It wasn't even close").
Subset analysis may show that one group had brilliant results, but the FDA won't "believe" it until they run a ph3, placebo-controlled trial with that hypothesis built into the protocol.
IMO the "markedly" is being taken much too seriously. MT has a grandiose way of speaking sometimes.
Obviously, all the above is my opinion. I was one of the most bullish here since 2010, but I simply do not think that this story goes anywhere for at least 3 years. MLC is harder than HCC, and what are they going to do in ABLATE, start over? HIFU? RCW has a shot but that is 3+ years out, enrollment is very slow.
GLTA - hello to all the old bulls that might still be reading here.
-Trond
