Response from Pierre & Fredis much appreciated and informative. Thanks to those who posted. My one concern is the question regarding the FDA's timeline with Priority Review status and a possible Pediatric voucher. Neither Pierre or Fred went near that question. We may hear something today. If not, I think you have to assume something is wrong. The FDA rules for submitting the BLA and their reponse timeline is clear....60 calendar days for Priority and 74 days for Regular review. Because Fred said Prometic has responded to questions from the FDA and are waiting for an answer perhaps we are being considered for Priority but if we don't get something official very soon....