Posted On: 05/15/2014 1:48:23 PM
Post# of 5066
Re: cvinvestor #4297
"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.
What I get ; 1) no toxicity, no rejection from host, the hosts own fat tissue. No safety issues; merely bureaucratic process. It's like an expansion on a few paragraphs.
2)Opinion leaders support clinical entry; People are very very interested in this medicine and science. We will be seeing INSANE wildcards in the future; big $ watching this, big pharma watching this. Everybody wants a slice of the pie.
3) Safety studies the FDA requested (PAST TENSE) clarification on can be addressed in a timely fashion.
The clarification was already resubmitted on the 9th, it didn't take long. No new animal studies are required; it's an expansion on the documents supporting the preclinical animal studies for safety. These are already done and it is merely adding paragraphs and amplifying information.
And this: On May 9, 2014 the Company updated its IND with changes requested by the FDA and submitted them for review.
And this:the sponsor will be so notified, and the 30-day response
clock will not start until a complete response is received.
it was received on the 9th. 9th = June 10th IMO. +/- 5 days for who knows why = latest 14th?.
Middle of next month should see full clinical approval.
JMO.
Conclusion: Don't be silly. We have approximately 28 days from today til' approval. Well, 28 to 35 days or something.
What I get ; 1) no toxicity, no rejection from host, the hosts own fat tissue. No safety issues; merely bureaucratic process. It's like an expansion on a few paragraphs.
2)Opinion leaders support clinical entry; People are very very interested in this medicine and science. We will be seeing INSANE wildcards in the future; big $ watching this, big pharma watching this. Everybody wants a slice of the pie.
3) Safety studies the FDA requested (PAST TENSE) clarification on can be addressed in a timely fashion.
The clarification was already resubmitted on the 9th, it didn't take long. No new animal studies are required; it's an expansion on the documents supporting the preclinical animal studies for safety. These are already done and it is merely adding paragraphs and amplifying information.
And this: On May 9, 2014 the Company updated its IND with changes requested by the FDA and submitted them for review.
And this:the sponsor will be so notified, and the 30-day response
clock will not start until a complete response is received.
it was received on the 9th. 9th = June 10th IMO. +/- 5 days for who knows why = latest 14th?.
Middle of next month should see full clinical approval.
JMO.
Conclusion: Don't be silly. We have approximately 28 days from today til' approval. Well, 28 to 35 days or something.
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