HemaXellerate IND Timeline Based On PRs 2/5 - Fil
Post# of 5066
HemaXellerate IND Timeline Based On PRs
2/5 - Filed IND for HemaXellerate
3/18 (Exactly 30 Business Days From 2/5) - Received IND #15376 from FDA and states that they will have questions that need to be addressed (letting them know they don't have the green light)
4/4 - States that FDA has advised them that their questions would arrive "shortly"
5/20 (32 business days from the 4/4 PR) - BMSN filed answers to the 1st round of questions (Mind you that we don't know if BMSN received the questions 2 days later or a week later than 4/4)
6/21 (24 business days from BMSN's response to 1st round) - BMSN receives 2nd round of questions from FDA
7/17 (16 business days from receiving 2nd round of questions) - Our own PatientGal states she spoke with Thomas Ichim on this date and that he confirmed that the answers to the 2nd round of questions had been submitted
7/31 (26 business days from receiving 2nd round of questions) - BMSN states that they are still in 2nd round of questions meaning we have yet to hear from the FDA if it is approved or if there will be a 3rd round of questions. It also doesn't state specificly if BMSN has submitted answers to all of the 2nd round questions but it has attached to it a figure representing data that the FDA had requested. (It's possible at this point that we had responded or have yet to respond to the 2nd set of questions fully)
Possibly Key Dates:
8/28 - 30 business days from 7/17
9/11 - 30 business days from 7/31