Re BTD:J.Lalezari stated in the recent HCW presentation,
Re BTD:J.Lalezari stated in the recent HCW presentation, around the end:
"In terms of the FDA and potential partnerships: partners have been wanting to see data as monotherapy, and they wanted to see prospective data. So we are confirming the durability of these exciting safety and efficacy readouts from the Phase 2 CLOVER study. We will be presenting the biomarker data and early clinical data at ESMO, and we plan on putting together a package for the FDA and submitting that for Breakthrough Designation before the end of the year. We are presenting the updated biomarker and more extensive clinical data at ASCO GI, and throughout, a top priority for CytoDyn is our continued evaluation of strategic partnership opportunities."
Credit to MGK, he posted the transcript on Reddit.
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