RE:Important statement by FDA Commissioner Scott GottliebHave yet to validate the source, but if true, this is significant indeed. This forward-thinking perspective could offer a less stringent path to success for Spectral. And that of course would be better for every single person that its solution saves.
hmmmmmmmm wrote: The agency seems to now have a deeper view than just black and white, pass/ fail. This feels so relevant to Spectral's "intereactive review process' with the FDA.
"Accelerated approval allows the agency to approve drugs based on substitute measures of clinical benefit. For example, cancer drugs that cause tumors to shrink are considered likely to confer a meaningful clinical benefit, such as survival.
The same principal could be applied to drugs which appear to increase survival in a small number of people, Gottlieb said. It could be determined later whether the benefit was statistically significant."
https://mobile.reuters.com/article/amp/idUSKBN1DU2DS