February over with no news. What's the nwbo excuse of the month for March, 2021? | NWBO Message Board Posts

Northwest Biotherapeutics Inc.

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Msg  14313 of 14407  at  3/2/2021 10:17:21 AM  by

Hodag


 In response to msg 14312 by  longfellow95
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Re: February over with no news. What's the nwbo excuse of the month for March, 2021?

NICE will not be the first opinion you see out of the UK simply because NICE is prohibited from making recommendations on any product that does not yet have MHRA approval.  Companies can parallel process the approvals, undergoing MHRA review and NICE review at the same time, but a favorable MHRA opinion must come first. 
 
Similarly, unless Sawston has completed its manufacturing inspection and licensure, MHRA is not going to give its approval to the drug.  Unlike chemical entities where it is the molecule itself that is approved, the approval for proteins and cells is tied to the manufacturing site so manufacturing inspections and drug approvals normally happen together.
 
I do think NICE will remain the wild card.  They still operate under the 2013 cost evaluation guidelines which provide likelihood of approval for drugs costing less than 20,000 pounds per QALY, unlikelihood of approval for drugs costing more than 30,000 pounds, and a detailed evaluation for the ones in the middle.  Using the high end of the range, NWBO needs to demonstrate an incremental survival benefit worth 2,500 pounds (about US$3,500) for each additional month of quality life for the average patient started on its therapy. 
 
Given the cost of producing DC therapies and the inherently high death rates of patients failing GBM therapy, that is a challenging target for any product.  The company may have to emulate some of the gene therapy companies that guarantee a refund to the provider if a patient is not cured.  That removes a lot of the financial risk for the NHS and may provide the most flexible pricing.


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Msg # Subject Author Recs Date Posted
14314 Re: February over with no news. What's the nwbo excuse of the month for March, 2021? longfellow95 0 3/2/2021 1:47:05 PM








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