Replies to post #570383 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Thanks for sharing Lykiri.

[ilovetech]

Which is exactly the same common sense 101 logic I had posted a while ago, when this came up. There's plenty of analysis paralysis to go around. But hey, for some, it helps pass the time.

ILT

[flipper44]

Perfect. Thank you Lykiri. So it appears that while NWBO was incorrect about Advent needing an MIA license before an NWBO MAA submission; thankfully, an MIA license can be granted without a preceding MAA submission. Good news.

[Chiugray]

Thanks Lykiri.

Translation: All you need to apply for MA (marketing approval) is to have submitted an application for MIA, which means NWBO could have already submitted the application for MA.

An MA application requires the company to state the site of manufacture of the product.
The expectation is that this site will hold an MIA or have applied for one if in the EU/GB 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.

Translation: That means if NWBO has already submitted the MA, then once the MIA is approved, the MA approval could quickly follow.

An MA will not be approved until the manufacturing site has a GMP certificate in place.

[eagle8]

Thank you Lykiri for your good work.
Nice to have clarity about this much-discussed part of the approval process.

Best.

[dmb2]

Lykiri, thx, this shows the MHRA approval process is basically the same as the FDA, MHRA will inspect and license the mfg site before marketing approval but not as a pre-MAA submission required step.

This makes a lot of sense and correlates to the Dr Zivic commentary. All good here.

GLTA

[ae kusterer]

Lykiri: Impressive ! It has been suggested to me that you and I talk. If that is amenable , please email me your cell number to: [e-mail] .Thanks.

Re: flipper44 post# 569715

Thursday, February 23, 2023 12:44:28 PM

Post#
570383
of 570808
flipper44,

I have messaged Richard Parker, Senior GMDP Inspector - MHRA London, asking him to further define, via a response, what they (MHRA) mean when they state " the product is in the process" of being approved. (actually your question.)

My email (Feb. 22, 2023)

Hey Rick,

I have a question regarding this paragraph:

“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.”
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences.

My only real question remaining is what does it mean to say the product must be under the “process of being approved” in order to obtain an MIA license. When does “in the process of being approved” begin for eventual marketing authorization — for purposes of MIA.



Response today:

Dear XXXXX,

Thank you for your email.

An MA application requires the company to state the site of manufacture of the product.

The expectation is that this site will hold an MIA or have applied for one if in the EU/GB 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.

To apply for an MIA the applicant should have a particular product in mind that they intend to manufacture. 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.

I hope that this clarifies things.

Kind regards

Rick

[Lykiri]

Linda Powers - Dec.30, 2022

But as I've said, an application for product approval is our top priority and laser-focused.
We plan to file -- we have to get the commercial license first when I was just talking about. That is a prerequisite before being able to submit the application like the PIP, the pediatric investigation plan was a prerequisite. We had to get that done. So we have to have that. But our time line is to file as soon as we can. And we also plan to be strategic about filing in multiple places.

I share here my latest correspondence with Richard Parker, Senior GMDP Inspector - MHRA- London.

My Q.:

"Is the MIA approval a prerequisite for MAA submission?"

Reply from Richard Parker:

Dear XXXXX

The MIA process is separate to the MAA process so as long as the potential MIA applicant has a clear vision of the product they intend to manufacture then an application can be made prior to an MA application. They must be GMP inspection ready and be able to demonstrate the capability to manufacture the final product during the inspection.

Kind regards

Rick