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biosectinvestor

09/18/21 2:13 PM

#402745 RE: HappyLibrarian #402743

You’re ignoring the reality. For instance EAMS was the PIM designation and they have been providing early access in the UK for years now. The facility in London and now Sawston will expand their capacity for EAMS. Which is early access.

The HE situation was new. Turned out the Germans snuck some protectionist provisions in it. It was given. It was awarded. So they went for it and got it. But early access under the HE in Germany required local manufacturing and that would be a diversion of resources and a waste when they needed them to keep focused.

On the prostrate trial, had a partner stepped forward to find it, or had their share price risen commensurate with the potential of DCVax, possibly they could have funded it, but they chose to limit their expenses and concentrate on DCVax-L, which is a significant partnership effectively with UCLA and burnishes all of their efforts with a whole additional level of impressiveness.

So I would look at the situation differently than you just painted it, which is a notion that they never finish anything, which again, if one believes in the science and remains invested for that reason, is a strange argument to make.

As for the change that became apparent on the announcement of results, it may have come only once they started discussing with what is ultimately a large number of advisors which was in that list originally. Their process. They had to reemphasize it. It is it just up to management to say what was the wisest course and they got advice to do it another way, is my guess, and of course it would come after they had it and had coordinated with all of their advisors. You make it sound like that is some sort of crime.

And there is no such thing as Buzdargate. Buzdar had nothing to do with this trial. He was never connected to it. He was just some random doctor that AdamFuerstrin got to make an unflattering comment, and who later violated his own statemsnts on this trial with statements in his own trial. That there are such people in research and the medical medical world that can almost be rented and rolled out to be used as a means to sabotage someone else’s trial, and help manufacture a controversy, is a reality. I have seen it multiple times with cell therapies. We do not know what his true motives were given that he broke his own supposed rules subsequently, he seems to have not been entirely sincere though certainly, momentarily he created some MINOR controversy that has no impact in reality. It does not affect the science, it does not affect any of the regulatory authorities, it did not cause any consequential legal claims. Nada. It had NO impact. Therefore it was not the equivalent of a “watergate”. It was a tempest in a teapot, ultimately.

Some can keep harping on these inconsequential loud noises and false light controversies. Note that Adam focused on the German laws failure, but made it seem like it was NWBO’s fault when basically that law was announced by the Germans with great fanfare and has produced very little for Germans in any context. It was not NWBO’s fault that they took the German regulator seriously on what seemed like an opportunity and did everything they were supposed to do to qualify DCVax-L other than move their manufacturing to Germany. You and AF make that sound like they committed a crime by successfully jumping through those German hoops. And who knows, there may still be some future regulatory benefit from that designation at the time of their application for full approval. They had to do a lot of work to get that certification.

No, it is nothing like the never ending darkness you just painted in that post. This is what it is like when you invest in a microcap bio that has been under resourced and attacked non-stop by rivals.

Doc logic

09/18/21 11:20 PM

#402764 RE: HappyLibrarian #402743

HappyLibrarian,

Those are unjustified conclusions based on insufficient evidence that something could have happened but hasn’t yet. Top line data, journal article and submission of BLA could have been lined up for last year but then changed abruptly when expected demand had to be greatly increased based on interpretation of top line data. We don’t know but that remains a strong possibility based on the evidence of greatly increasing manufacturing capacity being created by Cognate/Charles Rivers Labs and the emphasis on Sawston certification while waiting on a journal article which is being tied into top line data release and perhaps an updated pre prepped BLA for submission based on the Flaskworks device and expected demand which may or may not have already been submitted by now but most likely will be submitted with other news so as not to run into any question about material news.
Waiting without definite answers is difficult and leads to all sorts of speculation but drawing unjustified conclusions out of frustration only points to bias being birthed from that frustration. Putting aside the frustration we can look realistically to the point that NWBO will start to make the recent financiers look complicit with NWBO in working against the common shareholders if TLD news does not come before the next financing so.. not a pretty picture with any more delays.
NWBO has entered the journal article time zone, is expecting a manufacturing update from Sawston, likely update news from their contract manufacturing partner Charles Rivers Labs on manufacturing capacity progress and or other, needs to make repayments on their loan which points to a need for financing with limited shares to offer for it and given hints that this would happen only after top line data. Throw in potential interest from Merck and others as a potential part of a quiet period and things look very interesting. Bottom line is due diligence tells me that Linda has worked tirelessly to get to this point and she will do everything in her ability to get news released in the best possible order and time frame. Best wishes.