Tuesday, August 02, 2022 11:22:34 PM
HyGro,
Per your previous posts,
"External doctors have little or no influence on FDA decision-making. The only time they do is if the FDA sets up an Advisory Board of leading experts to review the data, vote and make recommendations to the FDA. But even that. the FDA has overruled the AdBoard recommendation. Nowhere in a drug application process are MDs involved other than the AdBoard if there is one."
This is obvious per my previous posts regarding the FDA; the point about credited Doctor support for DCVax-L still stands and is valid.
"NICE doesn't care about speedy availability if the drug is not approved.
NICE looks at "cost-effectiveness" of the drug which usually means that drug companies need to "drop their pants" to get approved. If the SoC is a cheap generic, it makes it much harder to get approved at a significant price premium like brand drugs normally require."
This is also obvious per my previous posts as well. My post supports the fact
that NWBO's manufacturing facilities require effort to complete their facilities prior to approval. As for NICE, I already posted their link. NICE does not mention price points with respect to approvals. There is no mention to "drop their pants" to get approved. If the SoC is a cheap generic, it makes it much harder to get approved at a significant price premium like brand drugs normally require." This is your personal opinion not NICE's.
Roman516
Per your previous posts,
"External doctors have little or no influence on FDA decision-making. The only time they do is if the FDA sets up an Advisory Board of leading experts to review the data, vote and make recommendations to the FDA. But even that. the FDA has overruled the AdBoard recommendation. Nowhere in a drug application process are MDs involved other than the AdBoard if there is one."
This is obvious per my previous posts regarding the FDA; the point about credited Doctor support for DCVax-L still stands and is valid.
"NICE doesn't care about speedy availability if the drug is not approved.
NICE looks at "cost-effectiveness" of the drug which usually means that drug companies need to "drop their pants" to get approved. If the SoC is a cheap generic, it makes it much harder to get approved at a significant price premium like brand drugs normally require."
This is also obvious per my previous posts as well. My post supports the fact
that NWBO's manufacturing facilities require effort to complete their facilities prior to approval. As for NICE, I already posted their link. NICE does not mention price points with respect to approvals. There is no mention to "drop their pants" to get approved. If the SoC is a cheap generic, it makes it much harder to get approved at a significant price premium like brand drugs normally require." This is your personal opinion not NICE's.
Roman516
Recent NWBO News
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- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/01/2025 09:04:38 PM
