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Nemesis18

04/15/24 8:59 AM

#685213 RE: beartrap12 #685209

That is without doubt the biggest load of speculative BS I have ever read on this board 🤪

Get yourself near a defibrillator, as you’ve seriously overdosed on hopium. In fact, your so smacked up on it, put a paddle up to ear ear, to hopefully reset your brain 😨🤯
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manibiotech

04/15/24 9:12 AM

#685215 RE: beartrap12 #685209

Actually that raises an interesting question : has MHRA ever allowed a drug in specials program and then denied approval ?
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brooktrail1933

04/15/24 10:42 AM

#685236 RE: beartrap12 #685209

There is bridge financing approved for the time between approval and NICE decision (about &375 million).
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hyperopia

04/15/24 10:57 AM

#685240 RE: beartrap12 #685209

beartrap, I’ve never seen a treatment that was approved for compassionate use, which later received commercial approval, but I’m unsure if this situation is truly unique. Once DCVax receives commercial approval, I doubt any more patients can be accepted into the Specials program, as it’s only for unlicensed medicines. For patients that were already accepted, they would have already begun treatment and paid for the initial treatment doses. (imagine being that last patient who had to pay for his own treatment, and just discovered that DCVax received commercial approval - ugh!)

I know the NICE assessment process starts earlier so there isn’t as long of an interim waiting period after a drug receives a commercial license, before a reimbursement decision is made, but I think it still could be up to a couple months after commercial approval. The Cancer Drug Fund may cover the cost of some treatments in the interim period until a NICE reimbursement decision is made, but there are limits, so I doubt they could cover everyone if there truly was a rush of patients.

I have reasons to think that the plan has been to start commercial manufacturing with the automated Flaskworks process, even if it occurs a few months after approval, but I’ve admitted that could be wrong, and I’m open to other possibilities. Everyone is certainly free to have a different opinion and believe whatever they wish.