Updated BMSN/Regen BioPharma Timeline for IND Appr
Post# of 5066
Posted On: 05/19/2014 8:26:47 AM
Updated BMSN/Regen BioPharma Timeline for IND Approval According to S-1/A and PRs
9/24/13 - Began additional efficacy tests (Estimated to last 3 months according to S-1/A)
(This is the testing the PR on 12/11 was announcing the completion of)
12/11/13 - Additional safety tests were already underway (Estimated to last 2 months according to S-1/A)
(This is the testing Dr. Min stated was already under way on the 12/11 PR)
2/11/14 - Safety tests should be completed
3/06/14 - Modified protocol for Phase I Clinical Trials submitted, additional manufacturing details for HemaXellerate submitted, new data regarding therapeutic effects of HemaXellerate submitted, and additional safety data submitted to the FDA
FDA accepted the clinical protocol and the manufacturing details for HemaXellerate I and requested clarification on a safety study.
5/09/14 - Submitted the additional safety data to the FDA for approval
The FDA has (30) days to respond to the additions to the IND request. Barring another set of questions, we should hear something by 6/13/14 counting 30 days and a 5 day window for the company to report potential approval in.
9/24/13 - Began additional efficacy tests (Estimated to last 3 months according to S-1/A)
(This is the testing the PR on 12/11 was announcing the completion of)
12/11/13 - Additional safety tests were already underway (Estimated to last 2 months according to S-1/A)
(This is the testing Dr. Min stated was already under way on the 12/11 PR)
2/11/14 - Safety tests should be completed
3/06/14 - Modified protocol for Phase I Clinical Trials submitted, additional manufacturing details for HemaXellerate submitted, new data regarding therapeutic effects of HemaXellerate submitted, and additional safety data submitted to the FDA
FDA accepted the clinical protocol and the manufacturing details for HemaXellerate I and requested clarification on a safety study.
5/09/14 - Submitted the additional safety data to the FDA for approval
The FDA has (30) days to respond to the additions to the IND request. Barring another set of questions, we should hear something by 6/13/14 counting 30 days and a 5 day window for the company to report potential approval in.
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