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marzan

10/02/20 10:55 AM

#313496 RE: biosectinvestor #313488

very possible. I have never seen Companies applying for RMAT announcing a PR about their applying. I have seen the list of companies won RMAT desination. I think Companies release PR after they receive the RMAT Designation from the FDA. So, I don't think we see a PR about RMAT status from NWBio. One requirement to apply for RMAT is TLD or some kind of efficacy proof even from Phase 2, imo. We got all those Safety and Efficacy Testing results. I see no wonder LL is presenting exactly the same thing as her Late Breaking at SNO. Connecting the dots.may be they expect to announce the designation by Nov 20..is interesting indeed!
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Doc logic

10/02/20 11:13 AM

#313504 RE: biosectinvestor #313488

biosectinvestor,

That is also a very good possibility, maybe even more likely, and one I have considered. I just think a rolling BLA is good for small companies and that Orphan Status gives them some additional help. Best wishes.