News Focus
News Focus
icon url

biosectinvestor

08/02/22 3:27 PM

#500482 RE: Roman516 #500424

Yes, the company did not draft those presentations, doctors who are not employed by and do not in most cases own shares in NWBO drafted those presentations. Dr. Liau is quite careful with her disclosures and avoiding any suggestion of conflict of interest or business interest in NWBO’s particular success.

The various doctors involved and the statistical firms involved are reviewing specifically as outside reviewers. If the trial had in fact failed, it is doubtful there would be so much support from the broad array of doctors in this trial. That’s the first arm of objectivity. Then you have the enthusiasm of non-profits on multiple continents and patients. You have the PIM designation and the HE designations, that came from regulators reviewing the trial during its course and suggesting very positive and carefully arrived at conclusions. Neither designation was ever revoked, regardless of negative posters suggesting they provided no benefit.

There are many objective sources to suggest that there is much positive interest and many in support of this treatment that come with a high degree of authority. UCLA still comments prominently and glowingly of DCVax-L research on its website.
icon url

HyGro

08/02/22 7:27 PM

#500553 RE: Roman516 #500424

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.

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.