Replies to post #31759 on Revive Therapeutics Ltd (RVVTF)

[alabama1man]

I honestly didn't expect this submission until later this week or next (the last posting about a conversation with MF happened a week ago and he said he expected it in about 2 weeks.

Question now becomes will the FDA take 30 days to respond or have they been in the loop on this and can respond a bit quicker. Either way it will probably be June before we hear.

[PennyWorld]

This turn of events is exactly what happened to RLFTF. They had to seek permission from the FDA to change their primary end points because the efficacy was not meaningful. Once the endpoints were changed, then they had the efficacy. This whole process added MANY months to the whole process. They had other issues though that went beyond the need to change end points. They are now awaiting for the NHI trial results year YEND. The FDA process can be a longgggg and painful process!!