Excellent question. Not being an expert in FDA processes, here's what I think it might be related to outside of the "safety clarification".
This is theoretical, so if others have insights, please comment so we can all profit:
1. Feb 13th, BMSN submitted initial IND for HemaXellerate.
2. Results in 1st round of questions, then a second round of questions.
3. Additionally, FDA requested specific animal test trials for both effectiveness and safety.
4. Tests were conducted from late last year into early 2014 and filed with FDA along with modified protocols and manufacturing information.
5. PR states that modification and resubmission of IND based on FDA requests.
-So, is it not possible that in the back and forth process since Feb 13th, that the FDA approved aspects in light of changes substantial enough to the original IND that a new IND was requested simply in light of all those changes and their approvals?
In other words, the modified IND incorporates all the developments between Feb 2013 and May 2014 while the "timely response" to animal safety may still be in process and if successfully concluded, will result in a future submission of data for final approval of the modified IND.
That's what I'm feeling based on the wording of the PR.
Any company just a few pages of paperwork "clarification" away from finally initiating clinical trials would have expressed a lot more positive and finalizing statements in the PR to build momentum it seems to me.
They deliberately choose not to mention in an outright statement that they had responded to the safety clarification issues and were confident of a positive reply soon from the FDA.
Others?
This is theoretical, so if others have insights, please comment so we can all profit:
1. Feb 13th, BMSN submitted initial IND for HemaXellerate.
2. Results in 1st round of questions, then a second round of questions.
3. Additionally, FDA requested specific animal test trials for both effectiveness and safety.
4. Tests were conducted from late last year into early 2014 and filed with FDA along with modified protocols and manufacturing information.
5. PR states that modification and resubmission of IND based on FDA requests.
-So, is it not possible that in the back and forth process since Feb 13th, that the FDA approved aspects in light of changes substantial enough to the original IND that a new IND was requested simply in light of all those changes and their approvals?
In other words, the modified IND incorporates all the developments between Feb 2013 and May 2014 while the "timely response" to animal safety may still be in process and if successfully concluded, will result in a future submission of data for final approval of the modified IND.
That's what I'm feeling based on the wording of the PR.
Any company just a few pages of paperwork "clarification" away from finally initiating clinical trials would have expressed a lot more positive and finalizing statements in the PR to build momentum it seems to me.
They deliberately choose not to mention in an outright statement that they had responded to the safety clarification issues and were confident of a positive reply soon from the FDA.
Others?
Quote:I do understand where you're coming from with that take on the PR...however...what would they have been submitting to the FDA for review on May 9th if it wasn't the clarification?
The FDA already approved the clinical protocol and the product manufacturing information that they provided on March 6.
I think they spent roughly a month gathering info for the clarification and submitted it on May 9th...my reasoning is they submitted all this originally on March 6...they had to hear back within 30 days...the FDA then told them the protocol and manufacturing was approved but they still needed clarification....so they gathered whatever they needed for the clarification and submitted it on May 9th
