Replies to post #531363 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Yes. In the US it is the USAN name, but in most cases the drug will have an INN name and the USAN accepts that.

But as of now, mercidencel is not listed in either as being approved or even under consideration.

Not that sure how fast USAN works. They do have lists of names of consideration, and no mention of mercidencel.

But INN has a clear rule that the name will be published 4 months prior to approval so parties can object. And that has not yet happened.

IMO, this is all a minor point. But that they are just doing this now shows a lot about management and/or plans.

[hoffmann6383]

Very relevant quotes!

[biosectinvestor]

German, I provided sources that contradict this just the other day. If you don’t have the generic name WHEN APPROVED, meaning we’ll after they’ve been in an approval context, whether because they had a rolling approval or they submitted their application without that name, the FDA and local regulators have a mechanism for providing an interim generic name.

[ATLnsider]

This is true GermanCol, and it is consistent with my post from yesterday:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170431548

That is true. INN is managed and administered by WHO. It is also a required prerequisite before a new drug / biologic Sponsor (NWBio) apply for their new drug / biologic nonproprietary nonbranded name before they apply for regulatory approvals.

NWBio has satisfied this prerequisite requirement, and can now apply for DCVax-L regulatory approvals in the US, Canada, UK, Germany and the rest of the EU, then in the rest of the world (ROW).

https://www.ama-assn.org/about/united-states-adopted-names/apply-united-states-adopted-name