I have the same question, but given the reasonable assumption that Anavex does not have an agree upon SAP with FDA for AD, it might give Anavex an opportunity to negotiate one through discussion with FDA or a foreign authority which is disclosed in today’s PR:

You can't fix stupid.

Ashkan for a paycheck.

If,as longs assert, ATL-DCs are useful in all cancers then one has to wonder why BPs have not been launching trials to gain those indications.

NWBO had its endpoints bought in during their Special Protocol Assessment which permitted ECA's.. NWBO did not pull ECAs to then hope on a hail marry on FDA guidance regarding the use of ECAs

I believe that NWBio and the FDA have had frequent and ongoing conversations about the ECAs that were used. I believe these conversations go all the way back to before the the clinical trial data was unblinded.

As a result, the updated FDA guidance regarding RWD and RWE is not relevant to the DCVax-L Phase III trial.

BTW, nice bolding on that quote to make it look to the casual reader that the "if required" applies to phase 2. It does not, it applies to the clock stop. Learn that trick from Hoffman?

may depend on how long it takes Northwest Bio to respond to the MHRA’s information request.

The MHRA will evaluate a UK, Great Britain (England, Wales and Scotland) or Northern Ireland marketing authorisation (MA) application and reach an opinion within 150 days of a valid application being submitted. CHARLOTTE TILLETT partner https://www.stevens-bolton.com/site/insights/articles/uk-marketing-authorisation

Additionally, the assessment clock doesn't start until the application is validated, which could take up to 2 weeks from submittal.

The assessment time has been reduced from 210 days to a 150-days assessment procedure for national MA applications containing new active substances. This new accelerated assessment route for MAs does what it says, within 150 days after submission of the application, the MHRA is expected to evaluate and reach an opinion.

The assessment time has been reduced from 210 days to a 150-days assessment procedure for national MA applications containing new active substances. This new accelerated assessment route for MAs does what it says, within 150 days after submission of the application, the MHRA is expected to evaluate and reach an opinion.

The UK independent regulatory system has now been operational for a year. As part of the programme, the Medicines and Healthcare products Regulatory Agency (MHRA) has introduced significant adjustments, here are four of the most important changes: Shorter timelines to approval

The assessment time has been reduced from 210 days to a 150-days assessment procedure for national MA applications containing new active substances. This new accelerated assessment route for MAs does what it says, within 150 days after submission of the application, the MHRA is expected to evaluate and reach an opinion.

The rolling review is a new route for MA applications, where data is submitted and reviewed as it becomes available (typically in the order of non-clinical, CMC and clinical data) instead of waiting for the completed data package. The assessment cycle for each submitted module will be completed within 60 days. The final phase is split into two stages, with a clock stop (where required) after 60 days and a decision being reached by day 100

They may have had to answer a few questions and concerns before they can say the submission was complete.

From 1 January 2021 the MHRA is introducing changes to national licensing procedures,
including procedures to prioritise access to new medicines that will benefit patients, an
accelerated assessment procedure and new routes of evaluation for novel products and
biotechnological products.
Pre-submission scientific advice meetings with the MHRA assessment teams
(https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra) at suitable times during the
development cycle are encouraged. At the meeting the company may present their intentions,
a short summary of the dossier and raise any special issues such as requests for
consideration for conditional marketing authorisation (CMA) or marketing authorisation (MA)
under exceptional circumstances. Pre-submission meetings offer opportunity to enhance
joined up work with the HTA evaluation process

but my post was just trying to present the realistic timeline that the company itself had indicate

We recommend you email AcceleratedandRollingReview@mhra.gov.uk

The rolling review is a new route for marketing authorisation applications (MAA), where an applicant for a marketing authorisation submits modules of the eCTD dossier incrementally for pre-assessment by the MHRA rather than as part of a consolidated full dossier submission.31 dec 2020

hese scenario totaly disregard submission deadlines VS CHM meetings.

Hopefully they ll be able to submit before 30 Oct 2023, which brings for a CHM meeting on 25-26 Jan.

Then clock start 80 days.
Clock stop 60 days. (60 days extension may be require).
Then clock restart 70 days.

Mid Sep 2024. Or Mid Nov 2024 if clock stop need an extra 60 days.

30 Oct 2023 submission deadline for 25/26 Jan 2024 CHM meeting.
Then clock start. ~ 80 days for phase 1 assessment, Mid April 2024.
Then clock stop ~60 days, mid June 2024.
Clock restart, ~70 days -> Sep 2024 Approval (hopefully)

The Company plans to request that the MHRA review the MAA under the 150-business day process that the MHRA has established to accelerate the availability of new medicines for patients in the U.K."

Well what ultimately matters is that DCVax is approved on this first application (that as I recall, your narrative was that they’d never submit); it would be great for patients if it were sooner, but if it takes 150 days

Tick tock.

Overall survival (OS) is the gold standard to assess novel therapeutics to treat cancer. However, to identify early efficacy and speed up drug approval, trials have used progression-free survival (PFS) as a surrogate endpoint (SE). Herein, we aimed to examine if PFS could function as an OS surrogate in advanced Esophageal Squamous Cell Carcinoma (ESCC) treated with first-line immunochemotherapy.

Once the MAA is validated, the assessment clock starts, and the final phase should be completed within 100 days in two stages as 60 + 40 days with an intervening clock off period. A request for further information (RFI) may be issued by Day 60 and the applicants may discuss issues with the MHRA within 30 days. The clock resumes on Day 61 when the RFI response is received by the MHRA, and the CHM will be consulted, with the final decision on approvability reached by Day 100.

You mentioned “capacity” three times but the article you used as your example for a different company didn’t mention capacity once.

NWBO has focused on manufacturing readiness for the last few years;

I haven’t seen any evidence to suggest that would be a problem for NWBO.

the Agency concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.

As I’m sure you heard on the call, the company believes the primary issues are CMC (e.g., manufacturing).

the Agency concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence

Any big pharma not connected will suffer a debilitating blow so the bids for each indication obviously are worth more than any single entity could possibly offer for all.

It's under the 150 day national process. It doesn't mean it will take that long. We know that the average timeline is under 90 days per their yearly reports.

The Company anticipates submitting the MAA in approximately the next 30-45 days. The Company plans to request that the MHRA review the MAA under the 150-business day process that the MHRA has established to accelerate the availability of new medicines for patients in the U.K.

I've had companies that conduct trials in partnership with big pharma under cost sharing arrangements and, after positive results, are in a stronger position to negotiate better terms.