Replies to post #452262 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Gary, I do agree that the BLA / MAA submission processes to the 4 different regulatory agencies (FDA, Health Canada, MHRA and EMA) are separate from the TLD and journal release process.

I also agree that the Flaskworks certification process is also a separate process from all of the above-mentioned processes.

[biosectinvestor]

A quiet period declaration can’t be used in and of itself to avoid announcing something that has happened already. The point of the quiet period is to avoid premature disclosure of details that might cause issues with a regulator or two or create potential legal liability spawning lawsuits and/or to do both.

The reason people are discussing approval is not because approval is directly connected to release of TLD, by some rule, or hard connection, but because of possible practical reasons that have left that as a fallback to address issues that have yet to be resolved by more appropriate means by a primary regulator. Various circumstances could change that not just including resolution of the regulator’s delayed final announcement. So nothing is directly dependent on anything, but if you have an approval in hand, then other issues that may be a good reason for a journal to delay publication, dissolve. And so do regulatory and legal risks.

As for manufacturing, it is in the guidance and details from the FDA that they need to be able to readily produce DCVax-L to achieve any accelerated status, and they need that to get into special programs like Project Orbis, though the have PIM status in the UK and that covers a lot of ground on that across the board.

I agree that I do not think they necessarily need Flaskworks certified to be approved, just a practical plan that the regulator feels comfortable with, and I agree you definitely do not need manufacturing in place to publish TLD, but if you’re going for approval, any approval to address other practical issues, then yes, it can become a practical reason to have the scaling plan well in place, to get the accelerated approval that basically suggests you’re the new standard of care.

It’s like playing Jenga, lots of pieces, and some have fallen in a way that they have become unexpectedly connected or dependent or interwoven with the overall project, and pulling out one or another can have frustrating consequences, but in the case of this situation, it is not quite the same level of causality, it would be to ensure the proper legal of care to not scramble the effort and undermine it by unnecessary mistakes.

This is all my humble opinion. I have no special information but my due diligence and experience.

[biosectinvestor]

On the issue of Flaskworks.

Patents for cell treatments like DCVax are not on the cell itself unless you’re doing something to the cell, and then it is intellectual protection for the process.

A blood draw can be performed by anyone. The science, once a company does a so year set of trials and reveals all of the details of their science, becomes easily replicable.

The IP is in the processes, that create the drug, and for what purposes. Therefore handing off the Flaskworks machines to another company at this stage, when they can likely do the work themselves and control even more IP, probably improve processes and get even more important IP that they control, would seem like a poor idea. It could be done, no doubt and it does happen every day, but a lot of IP is best protected not just with patents but by trade secret, which has no expiration date. Much of what they learn in the process of implementation and evolving their systems is incredibly important to keep close to the vest, in their own facility. Yes, they have workers under contract in their factory, and under contract, but it is a much more controlled environment and the legal arguments for trade secret protection and IP protection are much tighter under these conditions. Plus they do not have a contract yet for commercial manufacturing with anyone else. They have other contracts, some of which create appropriate and still existing terms and options, but they can for now, while they are certifying the equipment, focus their resources and attention there, in their own factory, instead of on managing another company as well, that is geographically somewhere else.

[Poor Man -]

Say you, what is this quiet period you speaketh?

You mean that period wherewith the company shares no information - despite the materiality to its fair shareholders? Or do you speaketh of the lack of transparency and disregard that LInda Powers and Les Goldman have for their own shareholders so that they not knoweth. Oh wonder, is that the quiet period you so desire?

“All the world's a stage, And all the men and women merely players: They have their exits and their entrances; And one man in his time plays many parts.“