Replies to post #659747 on NorthWest Biotherapeutics Inc (NWBO)

[RobotDroid]

Yep, here come the always wrong timeline predictions. Have not seen a correct one yet, but knowing management, expect it to be twice as long as anticipated.
Months, not weeks.

[biosectinvestor]

The accelerated program is ILAP. 150 Days is the regulated timeline. I have been quite sure this fits that programs parameters for some time, the company is giving that timeline because they have been in consultation with the regulator. The regulator has gone so far as to allow them to sell, pre-approval, at full cost, to U.K. citizens, under the Specials Program, and to license their factory knowingly for such purposes, given open PR’s and discussions, again likely under ILAP, which is a program that starts long before an application is submitted and provides guidance and assistance planning their regulatory approach.

The regulators have strict requirements and follow their requirements. I won’t ever claim to know the future and all future statements are protected by the safe harbor, but regulators do not claim such protections. If it says 150 days, then that is the intention of the law, which is different than future statements for a regulator, not for NWBO. I would expect the MHRA to work hard to keep that deadline.

[CrashOverride]

I don't care if people disagree with me as MHRA will be making the decision while their own data suggests it could come in less than 150 days.

flipper44 and others have posted this multiple times:

PM2
Area: Medicines licensing, assessment of applications
Target description:

a) The assessment of applications for New Active Substances (NAS) Marketing Authorisations for UK/GB - 97% assessed within 80 days (National including Orbis and Access Consortium)

Target: 97% assessed within 80 days
2021/22 (2020/21) total: 92% (100%)

https://www.gov.uk/government/publications/medicines-and-healthcare-products-regulatory-agency-annual-report-and-accounts-2021-to-2022/the-medicines-and-healthcare-products-regulatory-agency-annual-report-and-accounts-202122