NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

iclight,

As I see it there are 2 potential manufacturing issues. The one with regard to the PIM approval is related to expected volume from "early access" patients. This might be a low end to high end demand being expected by regulators. If they expect high end demand then production must be approved at or very near commercial level capacity before approval will be granted. The wording "able to supply the product" seems simple to do as your example suggests but the reality is that there is an unmentioned and expected demand supply level that must be met before approval will be granted. This is why we are witnessing a manufacturing ramp up in 3 countries. This L manufacturing ramp up may also be a clever smoke screen for Direct manufacturing ramp being done side by side. This would be a very clever way to surprise those who don't like surprises. If Direct manufacturing is up and running before the trial starts then how long would it take to get approvals and become commercially available? Just a thought.

The other manufacturing issue that might affect the trial and HE negotiations is a potential manufacturing change request related to producing more vaccine from the same amount of tumor or utilization of UCLA's screening technique is a non manufacturing twist to all of this as well. The manufacturing issue would require an equivalency test to gain approval and Germany may have requested this in relationship to the HE reimbursement negotiations to help keep cost per vaccination down and or give patients a better opportunity with more vaccine produced. All regulators would need to be on board for this to happen. In the mean time, OS eventing continues in hopes of seeing a clearer separation between early treatment vs late treatment patients.