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Kam8

08/12/18 9:14 AM

#185883 RE: exwannabe #185881

Dear sir, do u know the histories of JUNO and KITE? They haven't announced anything but BO. KITE worth 11.9B. I just know BMS need dcvax to flight with Merck for cancer drug market. It's say 100Billion market.
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JTORENCE

08/12/18 9:23 AM

#185885 RE: exwannabe #185881

exwanna why do you waste your time with characters like this. He doesn't have a clue. The structure/content of his posts should tell you that. You are probably responding to an adolescent.
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longfellow95

08/12/18 9:30 AM

#185887 RE: exwannabe #185881

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!)
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flipper44

08/12/18 10:32 AM

#185891 RE: exwannabe #185881

The NICE appraisal process can and has, in the case of DCVax-l, started long before any potential NICE appraisal decision. Topline can be announced long before any potential NICE appraisal decision. Any potential positive decision from CHMP comes before any potential marketing authorization in Europe (aka: approval). Typically, any potential FDA approval decision for an American therapeutic would come before the NICE appraisal process concludes -- even sometimes before it starts.