NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

It's a personalized vaccine. A second inspection may mean that they wanted something additional not previously required, like more cryostorage. It doesn't mean they found some shortcoming or "problem", it can be a conversation about what this is going to require and concerns about things like capacity. And supply lines can add additional delay. This is a NEW kind of product for the regulators. They are being methodical and careful, meanwhile they re-approved the special licenses. It doesn't mean there was some sort of great "problem". They are also dealing with supply line issues, which she discussed and is mentioned. That also may be a cause of concern. Again, not necessarily some huge problem at NWBO, but a challenge can be caused by current global circumstances and a desire of the licensing agency to work through the issues it may have identified in discussions with the company during inspection. The reality is, you don't know and the fact that it is taking time for the MHRA to be sure I also predicted, but for different reasons, not necessarily problematized but because this product is new for the MHRA, they want to be methodical because their work will be further reviewed by peer organizations (e.g. the FDA) and they want to not have missed anything. And further the multiple tissue type and dosage storage issues are complex for something that may become the new standard of care globally, first for GBM but maybe for other tumor types as well. They have to be prepared to create samples even for off-label samples and for patients around the world and then keep that tissue after manufacturing.

This is nothing compared to what I've seen with other cell based companies trying to address concerns about their production, and I'd rather all the issues get worked out now than come up later.