I am of the opinion that the clarification was not completely dealt with on May 9th.
The wording of Koos' PRs have usually been 'carefully' worded. Note that Thomas Ichim says the clarification can be dealt with in a "timely manner" vs. "We responded to the FDA clarification requests with our revised IND on May 9th" which is what I would have expected if they had.
Also Koos emphasizes the normal process of the further questions from the FDA and doesn't say anything to the point of having responded to or met the needs of clarification. Instead he emphasizes the importance of the need to establish safety, which to me may mean more time to evaluate the results in the previous trial or something else.
My feeling is a few weeks to the extreme of another 2-3 month trial which I hope is not necessary.
The wording of Koos' PRs have usually been 'carefully' worded. Note that Thomas Ichim says the clarification can be dealt with in a "timely manner" vs. "We responded to the FDA clarification requests with our revised IND on May 9th" which is what I would have expected if they had.
Also Koos emphasizes the normal process of the further questions from the FDA and doesn't say anything to the point of having responded to or met the needs of clarification. Instead he emphasizes the importance of the need to establish safety, which to me may mean more time to evaluate the results in the previous trial or something else.
My feeling is a few weeks to the extreme of another 2-3 month trial which I hope is not necessary.
Quote:"Given the HemaXellerate I™ product is derived from the patient's own fat tissue, and numerous key opinion leaders support clinical entry of our product, as demonstrated by our peer reviewed publication http://www.translational-medicine.com/content...0-231.pdf., we are confident the safety studies the FDA requested clarification on can be addressed in a timely fashion," stated Thomas Ichim, Regen's Chief Scientific Officer and Board Member.
"The role of the FDA is to ensure the highest standards of safety for new products. We view the requested clarifications from the FDA in regards to safety studies as part of the normal process of FDA submission. Given that the HemaXellerate I™ possesses the potential to treat multiple conditions, we view the demonstration of safety as a fundamental step, which will position the Company to expand use of this 'stem cell drug' for multiple other indications," noted David Koos, the Company's Chairman & CEO. "Having passed the clinical trial protocol approval and the manufacturing approval, are major milestones for Regen."
On May 9, 2014 the Company updated its IND with changes requested by the FDA and submitted them for review.
