US Stem Cell Inc (USRM)

[cvinvestor]

Thanks.

So far, strongest argument I've seen is on page 9 within section C.

As analogously illustrated by the California Stem Cell case, porting the minimal manipulation requirement from section 1271.10(a) into section 1271.15(b) would effectively mean that the SSP Exception could not apply to any cell implantation procedures, because isolating cells from tissue would always, by FDA’s interpretation, constitute more than minimal manipulation of the tissue. Since the SSP Exception by its very terms envisions its application to cell implantation procedures, FDA’s interpretation simply cannot be correct.