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MI Dendream

12/04/21 1:46 AM

#423762 RE: MI Dendream #423761

And BY THE WAY…notice too another difference in the bags and I am not talking about the quality.

One says Neurooncology the other does not… subject to interpretation but weighing heavily in my favor. It is a question of whether specialty plus mechanism is similar enough to disease state plus mechanism. The reason it weighs my way is ABTA and those words BRAIN TUMOR came first. Do you understand that logic? ABTA could have been the acronym and that would have added quit a bit of confusion but they did not…

THEY SAID BRAIN TUMOR and it actually does not matter that it is the conference name, of this I have been directly told. Clarity undeniable, I will not debate this with anyone. The only choice left is do you turn and look the other way, and if you do does that technicality really matter to us longs because I can wait beyond early February 2022 but I do not have to worry one bit because LP and LL would not risk it.

She also said, properly save that tissue!

biosectinvestor

12/04/21 5:01 AM

#423770 RE: MI Dendream #423761

You mention the registered trademark. One key difference between the two bags.

The old bag does not have the ® symbol next to the DCVax image. So technically at that time, it was not presented as the registered trademark for a drug. The new bag does, in fact, have the ® displayed beside the DCVax image.

DCVax is, in fact, a registered trademark without the "-L". I originally looked up only DCVax, just to confirm it is registered. I did not see evidence that they have another version of DCVax with either L or Direct currently registered though they may have trademark applications pending.

https://trademarks.justia.com/862/98/dcvax-86298423.html

They did have an earlier registration of DCVax, prior to the November 2017, for an unrelated area to any product of which I am aware they are working, and that may have been merely to protect the name and if you don't use such a trademark after a time, you lose it. It did include veterinary uses, but also dental wax, herbicide, sanitary preparations, dietetic substances... I do think they did contemplate veterinary uses, and that is much less regulated than human drugs. Perhaps also some exceptions of which pharmaceutical trademark lawyers would be aware... That may also be why they could use the trademark earlier, though they appear NOT to have referred to it as an actual trademark, not including the ® on that earlier bag. So the subsequent registration for the products that they ARE making, closer to when they can actually use the trademark, makes sense.

https://trademarks.justia.com/owners/northwest-biotherapeutics-inc-892660/

I think they intend to avoid confusion for patients and the general public and just use DCVax and not distinguish L and Direct. Probably only doctors and hospitals need to know that there are two versions of the vaccine and why. The registered trademark is only for DCVax.

Also, the text under the DCVax in both instances appears to be substantially different though to be honest, I can't read the text under the older bag.

Under the new bag it reads "Personalized Immune Therapies". So it is both literally displayed as a REGISTERED TRADEMARK on the new bag, which is not the case on the earlier version, and it says what it is going to be providing as a product, a personalized immune therapy.

The key differentiation for the "coming soon" safe harbor is the use of a "drug's" trademark name, or its "proprietary or established name", which might be indicated by the ® next to the brand.

Additionally, the company did not have that trademark until 11-14-2017, and I have no idea when that older bag is from.

https://iclg.com/practice-areas/pharmaceutical-advertising-laws-and-regulations/usa/amp

“3.7        Are “teaser” advertisements (i.e. advertisements that alert a reader to the fact that information on something new will follow, without specifying the nature of what will follow) permitted?
FDA regulations permit “teaser” advertisements as long as they relate to a drug which has been approved for marketing by the FDA.  For example, FDA regulations allow the use of “reminder” advertisements (which only mention the name of the drug and not its use) and “help-seeking” advertisements (which encourage individuals with a particular condition to see a doctor without mentioning a specific product).  See 21 C.F.R. §202.1(e).  For an unapproved product, within certain limitations the FDA has permitted the use of either “Institutional Promotion” or “Coming Soon Promotion”.  With an “Institutional Promotion” advertisement, the manufacturer may state the drug company name and the area in which it is conducting research, but not the proprietary or established drug name.  In “Coming Soon” advertisements, the manufacturer may state the drug name, but not the area in which the company is conducting research.  Such options are not available for drugs bearing “black box” safety warnings.”



Given the trademark and the ® next to the trademark, it seems to me like they think something is coming soon. I could, of course be wrong, and the ultimate name of the actual product will, in fact, be DCVax-L.