Replies to post #664035 on NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

Thank you Hankmanhub and Gary for your input.

While the many pages in this submission may have greatly delayed
the entire process of MAA submission, LP's statements suggest that
this did not affect the particular delay she was referring to because it was
in her words an unexpected delay that was apparently resolved and by
doing so, gave the company and consultants the opportunity to upgrade
the entire application. Apparently this improvement was important especially
because the MAA was to be submitted not only to the MHRA but to
other regulators as well.

With respect to an MAA with the manual vaccine production, I agree with Gary that it
would be adequate for the UK and perhaps with time also adequate for the USA but
an MAA that includes a validation of EDEN, would be of much greater value IMHO.

However, let us assume that the upgraded MAA did not include the validation of the
EDEN automatic manufacturing system and will include only the validation of the manual
production. Now what was the reason that the post delay MAA was such an improvement?
Answer: we still don't know and as of now, I have not received any suggestions that seem
more credible than my suggestion.

"The Company and its consultants are working intensively to finalize this last key section of the MAA, after overcoming an unexpected delay in that regard. The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators."