CytoDyn has received FDA permission to submit a ro

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CytoDyn has received FDA permission to submit a rolling biologics license application for Leronlimab (PRO140), which the company expects to complete in October 2019,

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This gives me encouragement that they have the data for part 2 be done in October, part 3 requires the FDA to decision on stability. I'm not holding my breath. I suspect the FDA realizes these added constraints with 700mg have been frustrating, probably the reason for the language in the FDA letter about admittedly wanting to approve combo and mono.

Also, NP in his talk about accomplishments, basically giving the list of reasons we would not be at this point with mono and combo without him, said the FDA wanted to move combo to 100 patients (in 2017 I believe that would have been). It took a couple years to enroll 50 patients, enrolling another 50 would have taken a while. NP talked them into using safety data from the mono trial, linking the combo and mono trials together but to speeding up the enrollment issue with combo, but with the 700mg efficacy mono results much better than 350mg, they required 700mg data with combo.

Also the main reason CytoDyn was able to obtain Pro 140 to begin with, the FDA required a trial in unmet need first, so Progenics shelved it.

Given, no viral resistance breakthrough happened and the data in early 2000s showing Pro 140 superior to other ccr5 inhibitiors, those not cover all r5 strains, I'm not sure why the FDA required the long path to approval for Pro 140, others was able to bypass the unmet need category, but here we are almost at the end.

“While 76% of HIV patients have at least one drug resistance, we have not seen any viral breakthroughs in patients on Leronlimab (PRO140) monotherapy.”