Let's get serious for a second, but no more than that. BoB is excited about the 8K that Scilex posted today, Sept 11, 2023, which states "Scilex participated in the type C meeting for purposes of pre-NDA discussion with the FDA and is pending official minutes in writing from the FDA."
So, it is a Pre-NDA meeting which is a 21 CFR 312.47 meeting. That means it can be either
1. End-of-phase 2 and pre-phase 3 meetings; is a second P3 required?
2. Pre-new drug application/biologics license application meetings
When this happened is unknown but the meeting package for a Type B meeting must be delivered — At least 4 weeks before the formal meeting, so Late July or early August. The official, finalized minutes will be issued to all FDA attendees (with copies to appropriate files) and to the sponsor or applicant within 30 days of the meeting. So, it would seem, the response from the FDA will come in September.
Yea-but... the SEC does not require companies to disclose all material information. So, will the shareholders learn anything new? Does SCILEX have to disclose, probably not. Does SRNEQ have to disclose since it is in BK, probably not as no BOD member is on the BOD of SCILEX... but Elizabeth Czerepak, M.B.A. is Executive Vice President, Chief Financial Officer and Chief Business Officer for SRNEQ as well as SCILEX. Does that complicate things, do not know but as all things Sorrento, It's a secret.
