Replies to post #418448 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

The likely “problem” (if you want to call it that) is that they got their SAP approved in Late summer 2020, and knew they needed to be ready for the ability to expand to larger manufacturing by buying Flaskworks in Late August 2020, and initiating comparability studies. They also needed to get Sawston manual manufacturing method/facility certified.

[The Danish Dude]

In mid September (the last public statements prior to Oct 5) they said the hoped for results in a few weeks, by end of the month.

It was AFTER Oct 5 that they first said the TLD had to be coordinated with the publication. Even then they have never said the TLD has to wait on publication.

You're partly right. They did not publish the process BEFORE data lock. They did it IN the data lock PR.

October 5th. 2020 Data Lock announcement

The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.

LP again restated this during ASM

"So first of all is the process for Phase III trial results. We know everyone is very anxious to see the results of the trial. As I think everybody knows, back on October 5th [2020] we outlined the process that we would be going through to get to the stage where the results can be announced. And I want to assure everyone that the Phase III trial and the analysis of the data are the most important topic that everyone in this company is focusing on. It has the full focus and attention of our management and our Board as well. Every resource we have has been and is being brought to bear on it. As we say, ‘it is our number one, number two, and number three priority.’ There’s nothing more important to the company. I’d like to be able to go into the details that we know everybody is craving, and understandably so, but we are in a quiet period now, while the data are being reviewed and analyzed. We’ve explained the process that we’re going through, it’s six stages of various analyses and reviews by various parties. And I can assure everyone that we are committed to completing this full process that we outlined at the outset, back when we did data lock. And we are doing so with great care. To put this in context, this is a fourteen-year long, Phase III trial. It’s really important that the review process be of the highest quality. We really appreciate the patience of our long-term investors. We do understand how hard it is to be patient after all this time. But we do ask that you continue to be patient because we serve you best by moving carefully and thoroughly through all the stages of the process that we’ve outlined. So that’s what we have been doing and we will finish doing. That’s really all I can say at this moment about the Phase III trial process."

Here is a clue. There is a massive problem they are failing to disclose that is causing the TLD not to be PR'd.

People talk about delays like this being normal. Complete BS. If anybody has invested in biotech they have never seen this.

There's is no problem at all. They have continously disclosed why they've not PR'd TLD yet. Because they correlate with publication and it has been taking longer time due to Covid. Stated in PR's, at ASM and in Q10's.