Thanks for the share Dalts.Very interesting pivot by the FDA,...

Thanks for the share Dalts.

Very interesting pivot by the FDA, could be seen by some as a little alarming, but equally, for those with an unmet need - you would hope that 'some risks' are taken as long as they are mostly safe.

for us, we are unfortunately still wading through the old approach - needing to provide proof that the tox profile is safe despite no issues for MS patients at 200mg doses. Anyway - timing ......

we are nearing the main game however, and if we can actually demonstrate end point achievement - an accelerated approval in light of approval with no scientific concrete evidence should become a much more likely path.

I think Itsa has nailed it - the FDA has now created 'precedence' provided that (a) those staff are still in office and that (b) their approach has not backfired in the meantime with adverse effects from a decision such as Sarepta's.

Game time for PER!