NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Huh. Whatayaknow dennisdave? Would you like to apologize and admit that YOU were wrong? Do you recall this post of mine when many here were claiming approval is likely within 80 days?

This is my understanding of the 150-day assessment route that Northwest Bio intends to use to apply for marketing approval in the UK: There are two assessment phases, totaling 150 days, plus a clock-off period up to 60 days, so approval may actually take longer than 150 days. How much longer than 150 days, may depend on how long it takes Northwest Bio to respond to the MHRA’s information request. If Northwest Bio takes the full 60 days to respond with the information requested, then it could potentially take up to 210 days. Additionally, the assessment clock doesn't start until the application is validated, which could take up to 2 weeks from submittal.

The initial phase of assessment takes 80 days. Then the MHRA reviewers will request further information to clarify a multitude of complex issues in the 1.7 million pages, and Northwest Bio has up to 60 days to respond. When Northwest Bio’s response is received by the MHRA, this will start a second 70-day phase of assessment.

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and your response?

You are wrong on the 210 days and wrong on the clock starting on the acceptance of the submission

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

IF NWBO is confronted (which I highly doubt) with an RFI of 60 days max (and by high exception that 60 days can be extended) then those 60 days include the 150-day assessment period. So its 80-day assessment, 60-day RFI, and 10-day phase 2 for the final decision. What you are saying is 210 days which it previously was. Can you provide me with a reliable source that says phase 2 of the application assessment takes 70 days?

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

also wrong its after the submission of the application and also again the WITHIN 150 days

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.
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