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HappyLibrarian

01/12/22 5:43 PM

#434597 RE: dennisdave #434588

Is the source reliable because of first-hand knowledge or because they talk to people with first-hand knowledge?

That is a question you can answer without betraying who the ultimate source is, and the answer would give everyone a lot more insight into how trustworthy the information is.
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Doc logic

01/13/22 12:16 AM

#434656 RE: dennisdave #434588

dennisdave,

In line with your thinking but not yet really stated by me is that a reasonable timeframe for publication from data lock would seem to be 16 months if taking Covid into consideration. Beyond that would suggest strongly other things in play which may be in play anyway with Covid providing cover. The one thing that is more than clear to me than ever is that NWBO has no intention of getting ahead of themselves with regard to patient hopes for access to this treatment and yes, that means investors take a back seat to patients. My sense of things is that L will be made ready for commercial availability by NWBO by the time major patient demand occurs and NWBO will leave all others to bear the brunt for not making it available. This is Linda’s best leverage tool. Will Specials serve as a ramp up or would that be too slow of a process for desperate patients. I believe FDA and others may see this possibility happening and that biosectinvestor is correct about how far along comparability and equivalency has come. I can not prove but do suspect that Charles Rivers Labs May be in the process of a non binding, perhaps even limited, fitting out of sorts with the Flaskworks device now that Sawston is certified and doing their own Flaskworks comparability studies. That might constitute a “substantial” test drive without being a finalized contractual agreement as recently noted and discussed here about the last 10Q. And no, we don’t “KNOW” but the business genes in me tell me this is a realistic possibility that stays in line with not getting ahead of the “right timing” of events. This strategy would leave regulators in the hot seat unless access is given very soon after TLD/journal article. So how could they address this situation effectively WORLDWIDE unless access is granted ahead of BLA/MAA approval or simultaneously with a BLA/MAA approval after TLD/journal article whether done that way before or not? Do the charts point to a really long quiet period about to end sometime between now and the end of Spring? I believe sooner rather than later but the charts look like they actually factor in a kind of deadline of sorts which I also think points at regulators more than NWBO. Best wishes.