Replies to post #805740 on NorthWest Biotherapeutics Inc (NWBO)

[H2R]

That would line up with "we are continuing to be actively engaged. We are going through cycles of questions, follow-up questions, requests for clarification, requests for additional data, information."

If the Company is indeed in this window:

2. The Statutory 28-Day Response Window
Under Schedule 11 of the Human Medicines Regulations 2012, once that (hypothetical) letter arrives, the clock starts:

• The Deadline: The applicant has exactly 28 calendar days to submit their final "clean-up" response.

• The "Clean-Up": During this time, the company's "armies of consultants" (as Linda called them) work around the clock to revise the documents to match the CHM's exact requirements.

As opposed to another RFI.

Thanks beartrap12 (and of course, Lyriki!)

Best of luck to Patients, NWBO, and Longs!

[Lykiri]

Beartrap,

A CHM letter (the so-called ‘28-day letter’) is not a “positive-with-conditions clean-up letter.”
It is only used when the CHM believes it may have to refuse approval.
If CHM’s advice is positive, no CHM letter is issued at all — the outcome is communicated by the MHRA licensing authority, not by CHM.
I contacted the MHRA’s CHM Secretariat directly and received the following written response:

“Following a CHM meeting, a CHM letter will be issued to the applicant where the Commission holds a provisional opinion that it may be unable to advise the MHRA to grant authorisation, in accordance with Schedule 11 of the Human Medicines Regulations 2012.
Where the provisional opinion is positive, this outcome will be communicated directly by the Licensing Authority, and a CHM letter will not be issued.”

Here is the full correspondence.

Subject: Clarification on CHM advice letters following CHM meetings at Day 143

Dear Deepesh,

Thank you for your earlier response and for clarifying that CHM meetings typically occur around Day 83 of the initial assessment phase and Day 143 of the responses assessment phase, and that these meetings are routine for most innovative medicines applications, particularly novel therapies.

I would be grateful for some further clarification specifically in relation to the CHM meeting that takes place around Day 143 of the responses assessment phase, at which the application is considered following the applicant’s responses.
In particular, could you please clarify:

1. Whether a formal letter is always issued to the applicant following a CHM meeting at Day 143, where the application is described as having been “considered and advised on”, both:

- when the CHM advice is positive (including positive advice with no outstanding objections), and
- when the CHM advice is negative or indicates that authorisation cannot be recommended at that stage.

2 Whether the nature and legal basis of that letter differs depending on the outcome, for example:

- a routine CHM advice letter following positive advice, versus
- a CHM letter issued under Schedule 11 of the Human Medicines Regulations 2012 inviting written or oral representations.

3 Approximately how long after the Day 143 CHM meeting such a letter is typically issued to the applicant, particularly for innovative or complex products such as advanced therapy medicinal products (ATMPs).

Any clarification on whether this process or timing differs for novel therapies compared with more conventional medicines would be greatly appreciated.

Thank you in advance for your assistance.

Kind regards

REPLY

Dear XXXXX,

Regarding your email, please find below the responses from our Committee team:

1. Following a CHM meeting, a CHM letter will be issued to the applicant where the Commission holds a provisional opinion that it may be unable to advise the MHRA to grant authorisation, in accordance with Schedule 11 of the Human Medicines Regulations 2012.
Where the provisional opinion is positive, this outcome will be communicated directly by the Licensing Authority, and a CHM letter will not be issued.

2. The CHM letter will set out the grounds for the provisional opinion, including major objections and concerns.
The applicant will be given the opportunity to make written or oral representations to the CHM under Schedule 11 of the Human Medicines Regulations 2012 where the Commission holds a provisional opinion that it may be unable to advise the MHRA to grant authorisation.

3. For all innovative medicine applications, including advanced therapy medicinal products (ATMPs), a CHM letter is issued by Day 150.

We hope this information is helpful, please come back to us if you need anything further.

Kind regards

Deepesh
MHRA Customer Experience Centre
Communications and engagement
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone [phone]