Posted On: 05/14/2014 4:28:21 PM
Post# of 5066
Lets compile the key bits..
On March 6, 2014, Regen submitted a protocol modification, additional details on manufacturing, and new data to the FDA regarding therapeutic effects of HemaXellerate I™ in animal models of diseases similar to aplastic anemia in humans, as well as additional safety data.
The Company reports the FDA accepted the clinical protocol and the product manufacturing information provided, however, clarification on animal safety studies was requested.
Then
On May 9, 2014 the Company updated its IND with changes requested by the FDA and submitted them for review.
2 months between...
Can't see it being that long again.
Should be less than a month imo?
I imagine that this is a smaller submission and that it took about 2 weeks for prepare the data... since its already in could be very fast?
On March 6, 2014, Regen submitted a protocol modification, additional details on manufacturing, and new data to the FDA regarding therapeutic effects of HemaXellerate I™ in animal models of diseases similar to aplastic anemia in humans, as well as additional safety data.
The Company reports the FDA accepted the clinical protocol and the product manufacturing information provided, however, clarification on animal safety studies was requested.
Then
On May 9, 2014 the Company updated its IND with changes requested by the FDA and submitted them for review.
2 months between...
Can't see it being that long again.
Should be less than a month imo?
I imagine that this is a smaller submission and that it took about 2 weeks for prepare the data... since its already in could be very fast?
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