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CytoDyn Inc CYDY
(Total Views: 324)
Posted On: 07/09/2019 4:55:58 PM
Post# of 154982
Posted By: sjacobs26
Re: trding #4595
Great idea! Hopefully he will address some of the CC presentation around this.....if not we could write a Seeking Alpha article and get his attention to address our questions that way!

I think wording these questions is important also. No one likes to feel attacked, so asking to-the-point direct questions in respectful ways goes a long way in receiving a better responses by establishing more effective communication and setting a tone (especially in written correspondence).

General: Feedback or sentiment from FDA on Leronlimab in HIV (combo, mono, PrEP), cancer (TNBC specifically), GvHD, etc.

Combo: Can you lay out combo BLA submission timeline to include FDA meeting of 525 vs 700, clinical portion based on both dose scenarios and CMO portion?

Mono: Will this be addressed during the combo meeting addressed above? If not, when do you anticipate this being complete and to begin enrollment. Can you lay out mono trial protocol (# patients, dose levels, random vs. targeted based on CCR5 occupancy test results, overlap/induction/maintenance periods) trial approval, expected enrollment and overall trial timeline?

I have to run, I will come back and ask some more when I get time.














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



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