I think it was 100 mono patients, 50 could be from

I think it was 100 mono patients, 50 could be from combo rescue arm and 50 new enrolled patients with half being 525mg and 700mg (I could be wrong here?). I think the mono patients were requested only for safety data of the higher doses since the combo trial was over. The FDA was 'playing ball' with CYDY and not requesting them to enroll the more difficult MDR2+ combo patients to obtain this safety data for the higher doses of 525mg and 700mg. This is why NP says we were a victim of our own success. Plus this will strengthen their mono data in the future.

As others have noted, seems the FDA could've approved 350mg initially as they had that data already, but thought it was best to err on the side of caution and go for the optimal dose for initial approval. I would agree if it were not for having such a stellar safety profile in several hundred patients at this point.....and many resistant patients needing access to such a drug.

Maybe this will help with the final mono trial where they require less patients or a shorter trial? I'm not getting my hopes up for such, but if the FDA is 'adamant' about getting combo and mono approved this would be a nice gesture stating such IMO.

Please do your own due diligence. All my posts and comments are not to be considered investment advice.