RE:RE:RE:RE:RE:RE:RE:RE:New FDA Proposed Guidance on AA
Oilminerdeluxe wrote: I hope you guys are able to have a clue about what is going on. I have given up trying to understand what is happening or not.
No worries oilminer...this proposal should not apply to our current trial.
If the FDA is truly concerned about scientific integrity & patient health (not Pharma wealth), any future changes should reflect (at least partially) that stance. Single-arm trials are quite appropriate for those indications that have critical need (lack of other good options for a serious illness) &/or that have a scarcity of patients. I do think there will be more reasonable recommendations made by clinical/research experts that are in line with the above.
Having said that, we know how Big Brother & Big Pharma work, & when a proposal is made by either, that generally means changes will be made regardless of external input or independent opinion. Just have to hope the FDA doesn't overstep its regulatory bounds & they can find an appropriate middle ground that best addresses patient needs/health.
Generally speaking, proposed changes can become effective relatively quickly...if there are no significantly differing or adverse suggestions made by the public/outside experts, there could be a final ruling with an established effective date done in as early as ~5 months. Anybody's guess if there will be significant enough opposition to delay such a decision. I will give them my thoughts...