NorthWest Biotherapeutics Inc (NWBO)

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The way I view this approval timing is that RA's expect a balance of supply and demand in the product sales and marketing plan when approved, which can include a ramp up in supply to meet ramped demand. There are moving parts in both supply and demand here. Either DCVax-L will be approved for GBM (both r and n), or it will have an expanded therapeutic range, potentially significantly expanded. Either Eden has been added to the MAA or it will submitted and approved shortly thereafter. The original MAA plan as it was explained by LP did not include Eden and it was believed the original MAA requested approval for GBM only. The ramp up plan would have included Eden to meet GBM demand post launch.

Now if there is an expanded label NWBO is expected to have an expanded supply plan, both immediate and ramped as having the original 'artisan' mfg capacity plan would not make sense to support the launch of a product with a significantly expanded label. I think it is unlikely MHRA would approve DCVax-L for an expanded therapeutic range without an expanded capacity plan, both immediate and ramp. It starts with the label. So either the original approval will cover a large therapeutic range with a commensurate supply plan or both demand and supply will evolve rapidly post the initial approval.

I learned to respect when LG would state everything they are doing is breaking new ground technologically and regulatorily. This has all taken considerable time to get to market, more time than I have ever experienced, starting with the trial duration, which proved to be a worthwhile wait. In my experience the time that has elapsed post data lock and in particular post MAA submission would be explained by both an expanded label and an expanded supply plan though it is also possible it is all due to the first in class ground breaking science and approval process being cut through a government thicket with a lean technical support team.

I lean toward the former, expanded label and supply plan, but I have not been correct about timing here yet as this ground breaking takes a lot of patience which should pay off for all shortly as the science will now be allowed to explode onto the oncological community.

GLTA