Yes, I do also. Misiu is more bullish on full mono than I. I feel MDR0 Combo expansion is almost a shoe in, but this would be the first mono approval. So we are breaking new ground with a sometimes unpredictable FDA, which is why I’m not at 100%, more like 90%. That is up from 25% a couple years ago with the new 525 and 700mg results. The mono protocol should give us more insight. I’ve always thought 48 weeks with 400+ patients based other MDR0 approvals, misiu 24 weeks with much less patients. If she is right, I will be more bullish—the FDA giving leronlimab an easy layup shot for approval; I hope she is. We should find out soon.
Comparisons look very favorable at 700mg though to some approved combo drugs. With the overlap added at the beginning, I feel we hit 85%-90% at 48 weeks, maybe more, without the density test. The FDA gave an at least 70% number initially I believe. We should have a very exciting May.
Comparisons look very favorable at 700mg though to some approved combo drugs. With the overlap added at the beginning, I feel we hit 85%-90% at 48 weeks, maybe more, without the density test. The FDA gave an at least 70% number initially I believe. We should have a very exciting May.
