Sunday, August 12, 2018 9:30:57 AM
Somebody had to tell 'em I suppose..
Just to slightly clarify what you stated.
The NICE decision comes after EMA approval. Target time of within 3 months from approval.
But the NICE appraisal process runs parallel to the EMA appraisal, once NWBO has made their submission to the EMA.
So both will receive the full unblinded data at more or less the same time. And additionally, NICE will receive pricing proposals.
I imagine the various stakeholders will be asked again, to give their views, once topline data is publically released.
It won't be cancelled, or even completely postponed.
Best term is probably 'on hold.'
(Unless NWBO surprises us all, by unblinding and making all the relevant submissions in the next week or so. Unlikely!)
Just to slightly clarify what you stated.
The NICE decision comes after EMA approval. Target time of within 3 months from approval.
But the NICE appraisal process runs parallel to the EMA appraisal, once NWBO has made their submission to the EMA.
So both will receive the full unblinded data at more or less the same time. And additionally, NICE will receive pricing proposals.
I imagine the various stakeholders will be asked again, to give their views, once topline data is publically released.
It won't be cancelled, or even completely postponed.
Best term is probably 'on hold.'
(Unless NWBO surprises us all, by unblinding and making all the relevant submissions in the next week or so. Unlikely!)
Recent NWBO News
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- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/01/2025 09:04:38 PM
