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  • privateaphrodite privateaphrodite Dec 17, 2009 5:44 PM Flag

    ACTC FDA approval process

    This Board needs to be cognizant of the importance of this clinical trial to the FDA. This has to be one of the most watched IND submissions they have received this year. With religious groups, patient groups, scientist, public policy makers and the investment community at large monitoring industry developments, the FDA has many with vested interest just waiting to second guess ANY decision they make in this sector. They already approved and subsequently had to put "on hold" the first submission utilizing this technology. From an industry perspective that was "a disaster"!!! That clinical hold "calls into question" safety concerns that most likely "raises the bar" in the evaluation of pre-clinical data to support safety in any other IND submission utilizing this technology platform. We should anticipate that the FDA will be obsessively careful to make sure that everything is in order before they allow this trial to move forward. Rest assure that ACTC is mindful of this and has laid out a very conservative plan in their Phase I safety Trial which will again require scrutiny on the part of each Trial site's IRB. The fact that ACTC has identified a disease condition that has no cure, have announced multiple trial sites in order to move into a Phase II quickly once safety is satisfied, have a patient population with a disease indication that may qualify for Orphan Indication status, and are using some of the best investigators in the industry should bode well for eventual acceptace by the FDA. Each of those institutions have much at stake if things aren't done appropriately. ACT has disclosed a realistic timetable given the uncertainty of what issues may arise in the governmental review process. It is also appropriate to not disclose too much given the competitive situation. Geron is on an announced path to be ready for clinical trials by the end of the 3rd quarter. All ACTC has stated is that they anticipate a similar timeline. The CEO is responsible for policy and what he says, assuming he is quoted appropriately, should be the company position. That would timetable would appear to be a responsible statement that allows plenty of margin for unforeseen events. This company has come a long way in five years on a small amount of capital relative to Geron and the monolithic "not for profit" research and educational institutions. ACT's fight has been one that we should all want to know more about after they have successfully treated the first patients with a new technology derived therapy. The next 18 months apprear to potentially be very exciting for this company and the industry. All the yearend tax trading and investor repositioning not withstanding, this company is in a unique position being fully capitalized for two years, having the potential to move quickly on a larger clinical trial with a commercially huge market (dry AMD) and having "dry powder" and stock trading liquidity to develop some unique strategic options in 2010. Those of us who are shareholders are very lucky to be apart of their struggles and successes.

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