NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Logic dictates that you cannot (usefully) submit an MAA to the EMA, nor a BLA to the FDA, without a body of evidence regarding the effectiveness and safety of your treatment.

And you don't acquire that evidence, until you unblind your trial and start analysing precisely what you've got.



What you may be able to do in respect of the EMA, is get the ball rolling regarding an Accelerated Assessment.
under the PRIME (priority medicine) scheme.

Now NWBO might at least have commenced that process.
Though thinking about it, even that is unlikely.

Accelerated assessment

Accelerated assessment reduces the timeframe for the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to review a marketing-authorisation application. Applications may be eligible for accelerated assessment if the CHMP decides the product is of major interest for public health and therapeutic innovation.

Evaluating a marketing-authorisation application under the centralised procedure can take up to 210 days, not counting clock stops when applicants have to provide additional information. On request, the CHMP can reduce the timeframe to 150 days if the applicant provides sufficient justification for an accelerated assessment.


How to request accelerated assessment

Any request for accelerated assessment should be made at least two to three months before submitting the marketing-authorisation application.

Before submitting a request for accelerated assessment, applicants should seek guidance from the EMA procedure manager to ensure timely submission of their request.

EMA strongly recommends that applicants request a pre-submission meeting six to seven months before submission to prepare for evaluation under accelerated assessment. In this meeting, they can discuss their proposal for accelerated assessment with the Agency and rapporteurs from the CHMP and any other committees concerned, such as the Pharmacovigilance Risk Assessment Committee (PRAC) or the Committee for Advanced Therapies (CAT). They can present the data package and risk management plan they intend to include in their application.

The request for a pre-submission meeting should be sent electronically to EMA together with supporting documentation.

Under the PRIME scheme launched in March 2016, it is now possible for applicants to receive confirmation during the clinical development phase that their medicine might potentially be eligible for accelerated assessment.


Providing justification

Applicants for accelerated assessment should justify their claim that the medicinal product is expected to be of major public health interest, particularly from the point of view of therapeutic innovation.

For details, please see pre-submission guidance question: Is my product eligible for an accelerated assessment?


Evaluating the need for pre-authorisation inspections

The Agency has a legal obligation to verify that manufacturers applying for marketing authorisation as well as the studies they submit comply with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).

Applicants should provide information concerning GMP and GCP aspects so that routine GCP and pre-approval GMP inspections can be integrated into the accelerated assessment procedure.

If a need for an inspection is identified, it will be requested as early as possible in the evaluation procedure.

https://www.ema.europa.eu/human-regulatory/marketing-authorisation/accelerated-assessment


Mind you; even the Accelerated Assessment pre-meet talks about bringing along your 'data package'.

So, thinking about it, they haven't actually done the AA pre-meet yet, because they haven't got the data to hand...

As soon as they have the data, they should get this rolling.
Big priority.

Over the next few months, it may be worthwhile keeping an eye out for new active AA's under the PRIME scheme, which the EMA might list somewhere.

It's definitely advantageous going down the AA road (almost essential, I would say), because you get a pre-meet which identifies the issues you must think about, you get a 'rapporteur' who offers regular consultation, and holds your hand through the process, you get your inspections done, and you get your MAA decision at least 2 months quicker.

NICE will be shadowing and dovetailing, assuming you have also put in your submission to them, which also requires the unblinded data.
Unless Brexit creates further havoc, by requiring MHRA approval, rather than EMA approval, before a NICE recommendation can happen.