RE:RE:RE:FDA announces comprehensive regenerative medicine policyupcoming trials is right. we have been waiting years. lets hope they finally get the fda application right and we will see some trials next year.
Sonny7 wrote: Viosimiri, BNF offered some food for thought in his last post saying that the FDA and the new policies were like they were tailored for Sernova. I know that the design of Sernova's upcoming trial was very unique and amounted to submitting paperwork and data representing more than one facet only within the application. That might explain the length of time that it's showing for news on FDA status of the application. What I'm suggesting is that with the complexity of the trial design, the FDA had to make changes to accommodate the application. I believe that Sernova and the scientific mind of the CEO were instrumental in making the change to FDA policy as they pioneer into new technologies in and for the medical profession.
Could that mean that ongoing trials or applications of Sernova's peers might have/had difficulties in getting approval for their trials? Or rejected? In any case, new standards are now set.
just thoughts and opinions