Posted On: 09/28/2013 3:09:22 PM
Post# of 5066
After reading through the journals again and coupling this information with previous discussions had with Dr. Ichim, I don't believe what the FDA is requiring at this point relates to safety or efficacy. Rather, I believe it is more mechanistic--since it's fat derived svf making hematopoietic growth factors, the FDA probably wants more info on the growth factors and any medical situations that the growth factors may have adverse effects. And that is no biggie.
Given that this is new medicine (again, comparatively speaking) and there is yet a lot to learn AND the FDA has had a world of issues put before them based on lack of dd on their part, with subsequent patient issues, I would think that this is very good news. Again, the FDA did not say "get this out of here" and the good doctors have the opportunity to further prove their treatment is what they claim it to be. If this is the case (and am pretty darn sure it is) the required experiments will not take very long and the FDA will slap the seal of approval with Orphan Drug status.
That is what I have determined. If anyone wishes to argue this, by all means.
(And yeah, yeah, yeah, we still have management issues to figure out).
Given that this is new medicine (again, comparatively speaking) and there is yet a lot to learn AND the FDA has had a world of issues put before them based on lack of dd on their part, with subsequent patient issues, I would think that this is very good news. Again, the FDA did not say "get this out of here" and the good doctors have the opportunity to further prove their treatment is what they claim it to be. If this is the case (and am pretty darn sure it is) the required experiments will not take very long and the FDA will slap the seal of approval with Orphan Drug status.
That is what I have determined. If anyone wishes to argue this, by all means.
(And yeah, yeah, yeah, we still have management issues to figure out).
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