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Re: Maverick0408 post# 417937

Tuesday, 11/16/2021 10:30:22 AM

Tuesday, November 16, 2021 10:30:22 AM

Post# of 688456

I don’t know why they don’t have a chief medical/regulatory officer on their team who has experience dealing with CROs and regulatory agencies. Unfortunately, the NWBO team have limited insight into who the right folks are and how to deal with them. Don’t understand their strategy.



Yep. It is a huge, huge deal that nobody working for the company has any experience with the BLA process. It is possible that the company has hired a consultant to act as the CRO, but if they have, they have not complied with their duties under the securities laws to tell us that.

From their current cash burn rate, it is obvious that they are not doing any substantial work to get a BLA ready for filing, nor are they doing anything substantial to address commercialization, which I guess makes sense since they must be at least 2 or 3 years away from commercialization. If they released TLD tomorrow, it would take them well over a year to get the BLA filed, and that is assuming they hired a consultant to help them with that process.
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