Big boys get FDA Priority review.....

[kmall]

Not a shocker here.....

https://finance.yahoo.com/news/pharma-s ... 00665.html

[biopearl123]

In fairness to the FDA, if there is such a thing, these drugs are already approved for other indications.

[KTArsenal]

In fairness to those suffering with MDS, the FDA should've granted priority review.

I've looked and I cannot find FDA transparency in declining priority review when priority review request was granted years beforehand.

[biopearl123]

I agree they should have. I think the compromise will be a much earlier date for approval than the currently listed PDUFA date. If the FDA was true to their commitment to rolling review, then those modules should be reviewed and closed. All that remains is ADCOM: FDA please review and approve. On another note EHA abstracts to be made public May 14th.