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DrHigh

12/19/22 5:35 PM

#550816 RE: OncoJock #550814

How soon until we announce the application in your opinion? The steps to seeking marketing approval will hopefully be the straw that broke the camels back with regards to suppressed stock price.

Also curious if any company has ever received auth to manufacture and distribute under a specials approval, then received subsequent commercial manufacturing approval but then later get hold up from receiving commercial marketing approval?? We should scream this from the highest mountain that historically this means we are good to go and could and should happen within X time frame. Lets let the markets know this is for real and the rubber will be meeting the road sooner than later

flipper44

12/19/22 5:57 PM

#550823 RE: OncoJock #550814

That’s right. The last time we know that no MAA had been yet filed was November 17.

Nevertheless, the MIA commercial facility license at Sawston is a necessary achievement for ultimate DCVax-l commercial production.

What bears like to deemphasize and longs like to emphasize is that Sawston used DCVax-l production to prove the facility was capable of commercial production, and thus received the license.

Obviously Ex doesn’t want this to mean any overlap with the MA decision process, and obviously longs want it to mean even more than just overlap.

If you can wait until tomorrow morning, the company should update and answer many questions regarding their position.

I am part of the choir that believes, while MAA hasn’t been formally filed yet, there has almost certainly been a rolling submission of modules that will shorten the eventual MA decision.

Without going into how that process can be shortened or lengthened, it’s probably just best to wait for a (tomorrow?) PR before we speculate.

Anyway, this all is getting closer to wrapping NWBO with a neat little bow, potentially for some awaiting suitors. If I were short, I’d be worried that a potential deal of some sort could be much nearer at hand. Retail shorts could get severely burned, and it seems like they’ve been warned enough. Likewise, longs can never call something a sure thing, until it has happened. But retail shorts are truly playing with fire.

tryn2

12/21/22 7:20 AM

#551477 RE: OncoJock #550814

OncoJock: thank you for taking the time to answer...!!! I was in a hurry and used the wrong word.... yes, final manufacturing approval.... we've been waiting for...!!!! We are getting CLOSE!!! Thanks again....
Bullish
Bullish

OncoJock

12/21/22 10:29 AM

#551580 RE: OncoJock #550814

You're welcome Tryn2, except now it looks like I was mistaken. Apparently this is the annual renewal for the approval to make investigational medicinal products (IMP) that was granted to the factory by MHRA about this same time last year.

As others on this board have pointed out, this is good, but not quite the same as full commercial approval to produce medicinal products on a large scale for use outside of clinical trials. Advent's factory has not (yet) been granted this higher level of approval from MHRA. I think we're all hoping that full commercial manufacturing approval by MHRA will follow in a matter of days, based on some good due diligence research posted here yesterday by a fellow iHubber.

If so, then we might also expect to see a press release from the company posted shortly after the MHRA posts a notice of full commercial approval on its website.

-- OJ