Cytodyn Inc (CYDY)

[Mymani]

Explains fda-cms parallel review program with examples..also why CMS approval means game!


“CMS will not publicly disclose a sponsor being part of parallel review until the sponsor makes it public," said a CMS spokesperson. "The FDA statute doesn’t allow FDA to publicly disclose who is asking for FDA-approval. CMS does not want to get ahead of that process."

There are a lot of trials we are reviewing through the IDE program," Syrek Jensen told Medtech Insight following her presentation. "They're coming in and going through the FDA and they're asking us about the trials. There are a lot of informal conversations that we're having. So it's not officially part of the parallel review program, but there are a lot of communication going on that I think is positive.

Part of the reason Syrek Jensen says people don't hear about some of this work is companies work with FDA on trial requirements and the trials themselves for a long time. After that, manufacturers come to CMS for an NCD.”

https://pharmaintelligence.informa.com/resources/product-content/despite-only-two-parallel-review-success-stories-cms-touts-better-coordination