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Re: NICE review There are 3 different themes on NICE floating around the herd. 1) The total tools who think it is an approval. 2) The idea that the fact it is in progress could indicate the EU approval is near. Obviously March '09 (the publication date) is way too soon, that will not happen. I am surprised flipper has not thrown in the towel on this yet. 3) Now it is the NICE QALY and reimbursement rates as a reason for extending the trial. Problem with number 3 is two fold. . It would financially a bad move to intentionally delay and dilute in order to get a higher price in the UK. The extra profits that any such could bring will not come close to offset the massive dilution over the last year. .They could submit follow-up data with longer OS duration anyway. The trial was designed for an OS analysis after the final PFS data. Waiting to here the spin when NICE suspends or terminates it. BTW, A hard BREXIT will be a mess. MHRA has not been in the business of approving biologics, cancer drugs, ... for many years now. They will need staff and processes drawn up. I could easily see this being a 2 year plus delay for many new treatments if they can not negotiate a deal to stay in the EMA. |
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Msg # | Subject | Author | Recs | Date Posted |
11612 | Re: NICE review | longfellow95 | 3 | 8/19/2018 5:50:44 PM |