Replies to post #794775 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

So you are saying it was never about the labeling stage !!!!

[dmb2]

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

[kabunushi]

Just FWIW, I asked GZ if Eden is being folded into the current approval, and he replied in the negative.

[beartrap12]

Andrew, It's my understanding that EDEN has it's own pathway to approval as a device. I know that Les and Linda had always said they would begin with the artisan method, and likely will, but I believe EDEN is well along the way to being qualified/verified (whatever the word is!) for use in commercial manufacturing. Because of the very long time lag since when management and shareholders expected MHRA to make a decision on the MAA, I think there is a possibility (perhaps remote) EDENs have been made and installed at Sawston. We know that two suites were recently validated (right word?) for commercial use. We don't know which class of suites they were, but is it possible some EDENS are already installed and ready for use? We don't know. Is it possible we're close?
Frankly, I don't see MHRA waiting for the annual review of Sawston if a new device is ready for validation now. I think they'd go ahead and approve it, if it's ready for approval and integration into the DCVax-L treatment system.
Keep in mind, EDEN has already passed the equivalency test and been determined to be essentially "the same" as the artisan method. All they need now are engineering runs to be sure the new manufacturing-level EDEN operates properly and passes tests.
So, I'm basically saying/hoping EDEN has advanced to the point of being ready/almost ready to deploy by the time our manufacturing application is decided. Remember, management said in a recent SEC filing that they would begin manufacturing the EDENs to align with arrival at Sawston when the new quicky C-cleanroom is completed. Construction on that c-cleanroom was supposed to begin in the 3rd quarter, according to the Q10. So, construction may already be 4 months in. Almost complete??
Realize that management has never mentioned that EDEN needs to wait for an annual review of the Sawston facility to, itself, be approved.