Merck conundrum, page-68

Hey Joe (no Hendrix reference)-- Thanks for asking that, it made me go double check if it was a type-C meeting. Immutep has not said what type it is actually. I put type C because I misread an Onclive.com article, so that was my mistake--apologies. They did have a type-C in July last year which IMM specifically said was type-C (https://www.immutep.com/detail/immutep-announces-successful-meeting-with-fda-on-phase-iii-design-in-non-small-cell-lung-cancer.html). That said, I am not any where near an expert on this, I have just been trying to research as much as I can about it. Now after more digging and AI consultation, It's up in the air if type B or type C, but I think one of those is right. It seems Type-B is usually after a Phase II to discuss next steps (like move to Phase III), but can also seek accelerated approval and a type-b has a 60 day response timeline. This is what I found on meeting types https://www.fda.gov/media/184120/download Type B meetings include:“Pre-NDA and pre-BLA meetings, end-of-Phase 2 meetings, and any meetings to discuss surrogate endpoints or the potential for accelerated approval pathways.”

But it seems Type-C now has a special version specifically for surrogate endpoints and in particular using biomarker data. I know IMM has been making sure to get biomarker data on their trials, I don't know off the top of my head right now if they got that data with HNSCC. However, it may explain why they have been pretty focused on getting it (again my opinion). this is from AI:
Type C Meetings for Novel SurrogatesThere is an official, recently issued guidance specifically for Type C meetings concerning novel surrogate endpoints.These are for sponsors proposing new biomarker-based endpoints to support either accelerated or traditional approvals.Meeting request must include preliminary human data showing biomarker response and dosing tolerability fda.gov
Process & Timing:FDA responds to meeting requests within 21 calendar days,Schedules or responds within 75 days,

Seems also, if Type-B and they get acceptance to move forward with Accelerated approval, it will not be officially given until the confirmatory Phase III is established and started I think.

According to AI, the chances of getting approval for phase III is very high and the accelerated approval less so, but still a decent chance. I personally think it looks good with the latest news that the FDA is looking to expedite drugs for unmet needs, Keytruda recently getting attention and approval in HNSCC pre and post surgery (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-and-adjuvant-pembrolizumab-resectable-locally-advanced-head-and-neck), Efti's safety profile, both PFS and OS high results in the trial, and biomarker data (albeit possibly in other indications, but they show clear T-cell activity). I hope, and think they will, put together a really good package of all this to present to the FDA making a solid, fact rich push for AA.

So, I am hopeful, but might end up having to wait for a Phase III (which isn't bad, but will be a disappointment).
Hope I didn't confuse with the unsubstantiated certainty of a of type-C.
Cheers.