Replies to post #580939 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

This is, according to something Richard Parker from MHRA wrote to Lykiri a few weeks ago, the additional prerequisite certificate, necessary for an MA. You need MIA human and GMPC. Read the last sentence.

MHRA’s response to Lykiri a few weeks ago:

Richard Parker, Senior GMDP Inspector - MHRA London

(Cough emphasis below are mine)

An MA application requires the company to state the site of manufacture of the product (cough…Sawston/London).

The expectation is that this site will hold an MIA or have applied for one if in the EU/GB (cough….Advent now “holds” a commercial human MIA) or have an EU/GB GMP certificate covering the manufacture of that type of product if a third country at the time of the MA application (cough…. Cognate has EU/GB GMP certificate).

To apply for an MIA the applicant should have a particular product in mind that they intend to manufacture (cough, Advent used DCVax-l). This is because they will have to supply process validation batches for the MA application. These process validations will ALSO be inspected (as well as the facilities and quality system) as part of the MIA process before an MIA and GMP certificate can be issued. These are issued after a successful outcome of an acceptable Competent Authority GMP inspection.

An MA will not be approved until the manufacturing site has a GMP certificate in place. (Cough…. Published today, 3/27)

I hope that this clarifies things.

Kind regards

Rick (Parker)

[SemperFITrader]

Flipper, good question, why no PR? DI sleep at the wheel.