The interesting thing is that because it's the same compound (leronlimab) and the same formulation and delivery system (sub-cut injection, 700ml), commercialization for cancer isn't necessarily far behind combo HIV. The plan all along for mono has been to file a label expansion BLA (supplemental BLA, or sBLA), piggy-backed on combo approval, which in theory dramatically shortens the timeline for approval. In this case, the FDA will have already reviewed safety data and the CMC portion of the BLA filing. Essentially, with the safety profile leronlimab has demonstrated (and we expect to continue to see...), they'd basically just need to show efficacy. The same would apply for cancer, although positive cancer data will also be grounds for an application for Breakthrough Designation, which would speed the process further. In short, it's important to start generating cancer data as soon as possible, because the FDA is very likely to accept positive P2 data on an AA or sBLA track in this case.
Which makes combo both extremely important and very interesting. We all seem to accept that combo approval is a foregone conclusion as long as the company gets the CMC portion correct, and will be even more so upon the acceptance of the BLA by the FDA. Remember, something like 85% of NDA/BLA filings that are accepted by the FDA are eventually approved, and the vast majority of flat out rejections are predicated at least partly on safety issues. I acknowledge that getting the CMC portion right the first time is NOT a given, by the way, but should be correctable in the course of business if there is an issue. The pre-clinical and clinical data is a relatively obvious green light. But if that's the case... then acceptance of a combo BLA will be a very strong harbinger of (relatively) imminent mono approval, and (assuming positive cancer data and a continued benign safety profile) cancer approval. Not like the week after combo or anything, but much faster via the sBLA route than going for a whole new drug approval. This is why the company didn't fight harder to convert the mono trial to pivotal, by the way. The approval timeline is based on the combo timeline, so they have the time to run a small-ish trial and generate the best data that they possibly can in order to ensure that mono sails through and create the market buzz from hitting ~90% success rates in a trial or something like that.
This is almost certainly playing into why we haven't partnered for anything yet. Highly unlikely that anyone on either side of the table is going to sign anything prior to seeing what sort of cancer data the company generates. And, in my opinion, highly unlikely that a partnership doesn't materialize in the wake of positive cancer data.
It's going to be fun to watch this play out, because...
1) Good cancer data is likely to precipitate a major partnership.
2) A partnership is likely to not only clean up the balance sheet and put a halt to the Paulson rounds (crucial), but also bring Wall Street analyst eyes to CytoDyn. They're going to want/need to know who and what that company is that just partnered with Merck, or Roche, or whoever, because they need to know to understand what the BP just signed up for, but they'll also have to understand what CYDY has...
3) All of that is likely to happen in roughly the same time frame as a BLA submission for combo, acceptance of which will have all of the secondary effects I typed out above. The FDA has 60 day for an initial review period to accept a BLA or ask for more information, so there's a clock on the acceptance.
4) Analysts are going to very quickly realize the implications for forward revenue for this company.
This whole thing is like a very tightly coiled spring. When it cuts loose, it's going to go hard.
