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Thursday, 05/05/2011 12:16:09 PM

Thursday, May 05, 2011 12:16:09 PM

Post# of 92948
several mail topic ?'s,


Will EU Orphan Desig. get approved soon?

Yes, I would expect and see no reason this designation won't be approved at meeting now ongoing provided whatever issues that are on the table are resolved. Link to COMP meeting
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2010/06/event_detail_000288.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c3&jsenabled=true

Will the EU court ruling in March have any bearing on Orphan Desig?

It is very possible if the ruling isn't changed that it could have a big impact on hESC patents, trials and commercialization. Until the ruling is ironed out in some fashion, I wouldn't expect any current decisions on Orphan status or CTA's to be impacted, jmo.

If you are not familiar with ruling this article provides the gist of it, posted by CTY

"In Europe, regulations regarding embryonic stem-cell research differ from country to country. However, a ruling on Mar. 10, 2011, by the European Court of Justice of the European Communities denied patents on ES cells to Oliver Brüstle of the University of Bonn on ethical grounds. The court found that even if cell lines could be established without the destruction of embryos, the commercialization of human embryos was unacceptable, and contrary to public policy. This ruling may push European countries to adopt restrictive policies regarding embryonic stem cells and inhibit the development of ES-based therapies."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=61552950

Rock, is ACT putting all their eggs in one basket with all the same RPE trials?"

If everything "goes as planned" with 2 US trials and possibly the 3rd in EU somewhere (and CHA in Korea) it opens up a tremendous market in a relatively short time. On the other hand, a setback with one could possibly affect all of them. It is what it is, if I had a preference or a say in the matter I would opt for the 2US trials of RPE and Phase 2 of Myoblast starting in the much less controversial adult stem cell arena, again, jmo.

"rocky301, does the OS# and all that still concern you?"

Absolutely. Without hesitation I believe it is the major reason we are trading below .20. Float approx. 1.5B on the OTC is huge and imo we will not grow the pps to levels needed to meet bid requirements on a big board exchange. As mentioned prior regarding rs, Mr. Rabin has stated "he doesn't want to alienate shareholders". I understand the logic and appreciate that but also believe we are at a point with trials and endpoint results where ACT is alienating the instituional money and all the perks and exposure that come with a large exchange..again, this is opinion.

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