Replies to post #827982 on NorthWest Biotherapeutics Inc (NWBO)

[williamssc]

Spot on GGB. The amount of heavy lifting NWBO has completed in forging their way to approval over the past two years is astounding. Who knew they would be adding leuk clinics to help out the UK government. The need for GBM treatment is great.

[brazen22]

I agree these steps show commercial intent. I do not agree that they prove near term approval or direct positive MHRA signals.

That is the distinction.

U.S. tech transfer, SOP adaptation, training, validation runs, Sawston expansion, leukapheresis capacity, and Flaskworks integration are all consistent with a company preparing for commercialization. But they are also consistent with a company trying to satisfy manufacturing, CMC, validation, comparability, and capacity requirements that may still be unresolved.

That is why I do not treat these actions as proof that approval is close. They may be required steps to keep the approval path alive.

A cash constrained company can still make expensive moves if the alternative is worse. If NWBO cannot demonstrate credible commercial manufacturing readiness, then the MAA may not be approvable. So the spend may not mean “approval is assured.” It may mean “without this spend, approval is impossible.”

On your question, I would say these steps look more like near term commercial intent than a company planning to sit idle for 2 to 3 years. But intent is not approval. Preparation is not clearance. And expensive preparation is not proof of positive non public regulatory signals.

It tells me management believes they need to be ready. It does not tell me MHRA has already signaled the outcome.

You say a rational management team would not spend that kind of money unless it had high conviction based on direct regulatory feedback that approval is close. But if that regulatory feedback is strong enough to justify saying approval is close, then it sounds material.

If NWBO had received a definite or near definite positive signal from MHRA, that would seem like material information. If the feedback is not material enough to disclose, then I do not see how it is strong enough to support message board certainty that approval is on the way.

Routine regulatory feedback, RFIs, CMC questions, inspection issues, validation questions, and manufacturing readiness discussions can explain expensive preparation without proving approval is close. They may show what NWBO still has to satisfy, not what MHRA has already decided.

[meirluc]

For all the excellent reasons you stated, I agree with you 100% that all of NWBO's recent initiatives document that the company has no doubt that its MAA will be approved and is willing to bet its money on that. I therefore see no reason for the presence of any holdup of approval that is based on some hidden, covered up deficiencies.

Furthermore if the MAA approval is not dependent at all on any work related to upgrading the electric infrastructure and buildout of the Grade C suit, I am at a loss to think of a reason that is holding up that approval. Perhaps the slow navigating capacities of the MHRA has something to do with that.

Bottom line: I am confident of MAA approval but if not approved within the next month, hopefully we will know more by then what is causing the delay and again regardless of any delay, I am certain of approval.