Ocata Therapeutics Inc fka OCAT

[rocky301]

oman,


I will try and answer what I think you are asking. If I miss the mark, let me know.


You can go here and see what was available PRE-OBAMA. New guidlines were established by the NIH and to date only ONE LINE of the former 21 has been approved, the H1 line.(Warf/WiCell WA01)

"The NIH Stem Cell Unit (SCU) has analyzed and compared the 21 human embryonic stem cell (hESC) lines approved under prior presidential policy, which was revoked March 9, 2009, by President Barack Obama's Executive Order 13505. As per the July 7, 2009, NIH stem cell guidelines, the eligibility of the use of these lines in NIH-supported research will be determined at a later date."
stemcells.nih.gov/research/nihresearch/scunit/

Are all the NIH applications from ACTC for unapproved lines in the hope that they will become approved later

Absolutely. ACT has submitted 9 hESC cell lines to date, (8 are pending, one in draft). These are cell lines that have been developed by ACT in their Worcester GMP Lab. If/when any or all these lines are NIH approved and in the HESC registry other researchers may purchase the cell lines from ACT. This of course brings revenues to ACT and possible future funding for research/projects ACT has.

is our IND on hold because of the above removal of approvals

Absolutely NOT. Everyone must keep the following in mind. Cell line approval by the NIH means they are eligible for use in NIH-funded research. ACT or anyone else has every right to use a stem cell line that is NOT approved by NIH and pursue clinical trials through the FDA , just as we are now, keeping in mind their will be no Fed monies available for this approach.

Summary: ACT has filed the RPE IND with the FDA and have been placed on clinical hold. The RPE data was based on their own MA09 hESC line. ACT will respond to the issues that are of concern to the FDA. It will not be based on whether or not ACT's MA09 cell line is approved for federal funding by the NIH. IMO, it would be a nice "total package", for obvious reasons, if they were allowed to move into trials and have the cell line approved by NIH. Hopefully I answered some of your concerns, if not please let me know.