Replies to post #641419 on NorthWest Biotherapeutics Inc (NWBO)

[JMarv]

Thanks ATL

[FeMike]

I want to clarify and correct 1 point I stated earlier about the Project Orbis program

Haha what??

The entire point of your original post was to pump up how NWBO only needs to submit one application to one RA. You very succinctly said that it is a common misconception that they have to submit to each RA individually.

And now you follow that up with a “clarification” to say the exact opposite. That they do in fact have to submit to each RA individually.

“I do want to clarify one minor point about my prior post. That is, the entire post was made up and incorrect.”

Wild.

[pqr]

ATL - could you please explain the advantage of Orbis then since there does not seem to be material participation by MHRA beyond its initial approval decision? Does anyone think the FDA is going to be swayed by an MHRA decision? It is not my field but posters here don’t seem to think that way. Thanks for your thoughts.

[DJPele]

DJPele, another common misunderstanding that some people have regarding Project Orbis, is that NWBio would have to have a separate DCVax-L BLA / MAA submission date for each different regulator.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173029675

ATL....this is quite the opposite from what you posted this morning. So it appears my original point was correct?

[DavidW2]

So key is, DCVAX-L needs to be in the Project Orbis program. This is still unknown. You say it by assumption!

[manibiotech]

Again … that point would have been well known or should have been well known to management and consultants as I don’t think this is something new that changed this year . So how does that explain the delay and not able to meet the timeline

[erik007tc]

DCVax-L + Poly-ICLC pre-print Sept. 12 (Nature), when do we expect that peer review journal be publish in Nature?