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DavidW2

03/09/22 10:41 PM

#450098 RE: ATLnsider #450097

But the time NWBO spent to build manufacture facility and to get GMP license, it means NWBO is very sure TLD is positive, otherwise those time and money all will be wasted. That is common sense, otherwise it is not your money or your time and you don't care.

If NWBO are very sure about positive TLD, why keeps waiting on publications? Does an article can 100% prevent short attack? I doubt it!
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barnstormer

03/10/22 12:54 AM

#450134 RE: ATLnsider #450097

Concur that the time needed to complete the peer-review process is beyond their ability to control. Disagree that they lack any control over the TLD and journal article release. Assuming the review results and TLD are as good as anticipated, there will be more than one reputable journal anxious to publish, and the company can use that competition as a lever to arrive at a satisfactory result. In the end, just another contract that needs to be agreeable to both parties. If not, the company goes to a competitor.
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skitahoe

03/17/22 4:45 PM

#452262 RE: ATLnsider #450097

ATL,

I believe the BLA submission is completely independent of all these other events. The quiet period might very well be used as a reason not to announce it. I'm not saying it's been made, only that it could be without TLD, Journal, etc.

I think that when it's clear that the quiet period has ended we'll get an update on many things that are occurring.

Right now, I'm not sure that any submission is awaiting the acceptance of the FlaskWorks unit for production of the vaccine. If they're close to that, they'd want approval to clearly authorize vaccine made by FlaskWorks. I believe the agreement with CRL would be very different if they're licensed to use FlaskWorks in their facilities worldwide rather than tying up a tremendous number of their cleanrooms in making the vaccine for massive numbers of patients in much of the world.

Of course it's not totally impossible that on approval of FlaskWorks the company could either gain a partnership, or with increased shares authorized and substantially higher stock prices do the funding necessary to build say one thousand FlaskWorks units that they'd operate themselves. That would give them the capability of producing 50,000 vaccines a year on approval, and more could be added post approval. I believe it would be sufficient to gain approval. I'm not saying this is the case, just looking at possibilities. A BP partner would very probably want to bring production inside, they almost certainly would have the cryogenic capability, and if we mass produced the FlaskWorks units, they'd find the space to operate them from.

Gary

Like everything the company is doing, it's all hidden from view, but I believe they know precisely how they intend to get the job done, and much of the paperwork needed to make it happen may just be a few signitures away from being finalized agreements.