Replies to post #419980 on NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Hoffman, Look at the photo again. Do you see that little circle with an R inside next to the word DCVAX?

BTW it would be hard to say with a straight face to anyone that you are in a quiet period still if you started a coming soon campaign which if that bag is real…you did!

[Lykiri]

MI Dendream:

After a quick search I found this:

EXCEPTIONS FOR LIMITED PRE-APPROVAL COMMUNICATIONS

• FDA permits limited pre-approval advertising for investigational drugs and biologics:

• “Institutional” advertisements that state a specific drug company is conducting research in a certain therapeutic area to develop new and important drugs. (May not mention drug name)

• “Coming soon” advertisements announce the impending availability of a named drug product.
(May not include information on intended use, safety, or effectiveness.)

• A sponsor may use either institutional or coming soon advertisements for a drug, but not both.
• These ads are generally permitted within six (6) months of introduction of the product.
http://www.ehcca.com/presentations/pharmacongress16/reeves_ms15.pdf

Same here:
http://www.ehcca.com/presentations/fdasymposium3/casola_1.pdf
P.19

Pre-Approval Promotion

Sponsor shall not represent in a promotional context that an investigational drug is safe or effective

– Institutional:

• Company X is doing research in Y area of medicine
• Cannot mention any drug by brand or generic name

– Coming soon:

• Announce name of a new product that will be available soon
• May not make written, verbal, or graphic representations or suggestions concerning the safety, efficacy, or intended use of the product

[Fireman02360]

Not a stretch at all…the law.

There is no sort of "law" prohibiting a biotech for producing a tote bag with its logo. C'mon, you cant be serious. This is called advertising and any company that owns the rights to the logo, can print that logo on any "gear" they wish, regardless if its up for approval or not. Its absurd you are filling minds with this type of garbage, claiming its illegal to do so UNLESS DCVAX was on the FDA docket for approval.

-Fireman

[hoffmann6383]

I'm always skeptical so forgive me. I'd like to see your rule in question. Your trademark comment wasn't accurate bc we would know about it.