banter and General Discussion, page-7810

I agree.

I have not seen any thing to suguest that accelerated approval is not going to be granted. That would be for both children and adults. First we must show that the potentcy assay is good for adults and have the protacol past by the FDA.

CRL 2 . The FDA told us they could not be sure that current stock would be the same as stock uesed.

Type A meeting. No mention of above. Is new stock now considerd the same as old? They had the data of 71 adults. They say. We can not give approval due to regulation that required 001 product to be standadized.
The FDA are talking about full aproval in children, not AA.

So when a AA is given a trial needs to be in place.
Given that a current control is needed for the trial, accelerated approval will be limited to grade 3 and 4 that have failed that other approved drug. The trial could be very different to what SI has proposed, indeed for it to be controlled it has to be.

Given AA and the FDA remain in control, a gold standard standard cross over trial between the current approved drug and our product and endpoints pushed out to two years could be seen by the FDA as better than SI's proposed trial. This gives more reasons for the FDA to grant accelerated approval.