Replies to post #451665 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

That doesn’t follow, if anyone reads the full post. That is clearly just reasonable speculation. That some people don’t like that his or her post is quite reasonable and inconsistent with their own narratives is just the breaks.

Plus the post said it could happen even tomorrow. I think he only meant that approval and scale-up of Flaskworks or maybe just approval of Flaskworks as the new manufacturing method.

Personally, I do not believe they need to have Flaskworks fully approved for approval, I do think they are likely far along on that effort though and that the regs are not as difficult or worrisome as some suggest. In fact another company I am in, just got their new bioreactor manufacturing approved by FDA in the middle of a trial, and they do not yet have a fully functional factory yet. Updating manufacturing during the trial and/or pre-approval or as a company is moving toward approval is expected and they’ve tried to make it less difficult and burdensome by updating their regs. Plus the MHRA seems a bit ahead of the FDA on many of the reforms FDA is working toward now. We’ll see, but again, all just IMHO, I think they are working hard to address all the challenges based on results that from the interim look likely to be very, very exciting on revelation of TLD, but validation still requires that they go through certain hoops, some still being defined. These things, IMHO, seem to me to suggest that the concurrency of certain events would be advantageous.

[iwasadiver]

I look at the game on the field. I have lists, graphs, and hypotheses that I check all this against and create my perspective. All I’ve been told is that everything one would know that had to be done before going for approvals is being done in parallel and that amount of work is massive. I do not believe they’re pushing back release of TLD, but I think a strategy came into effect back when they expected to announce TLD in September 2020. The fact that Stupp came on board as an advisor at that particular time has a lot to do with things. I ask myself this question every day; what the f*** is taking so long? The mantra from the company has never changed…we’re working to release TLD and publish it in a journal. They have said nothing more to me and I’m not going to ask them.

I’m speculating but I have my reasons from things I read and hear outside of the company. Hints come in all kinds of forms and all kinds of sources. I consider this investment my second job as if I’m an investigator.I turn over stones, talk to people I know on Wall Street and in Pharma. They teach me things and tell me where to look for things, and how to read the tea leaves. I believe what I’ve come up with and I state it here because of my confidence in what I’ve put together. That’s it. All you have to do is read the last part of what you quoted me: “…this last particular part is key BECAUSE IF WE’RE THERE…” I don’t know any more than you or anyone else but I have my reasons to believe it from the way things are occurring.