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  • superserial Aug 30, 2010 1:36 AM Flag

    Maybe I'm being insensitive but...

    ACTC's application is not to inject stem cells into the whole U.S. population, we are only talking about 12 friggin people here. TWELVE! What's the worst that can happen to 12 people who are already faced with the prospect of going blind? The FDA needs to get off their high horse and just approve this tiny trial already....unless of course, there is some outside pressure influencing their decision.
    Please, tell me if you think I'm wrong here or insensitive, but the FDA has all the safety data they need and it's time to let 12 willing participants put this stem cell thing to the test. Dragging this thing out is rediculous.

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    • I do not believe you are insensitive here. Everyone is assuming that the FDA has ALL they need. No shareholder knows if this is true or not. If I was one of the 12 folks in this study I would want complete assurance from the FDA that it is at least safe to proceed. The FDA has a very bad past history on approving drugs that make it on the shelves because the companies say they are safe. Drugs for weight loss such as Redux, Fhen-fhen, Vioxx and there are many others. Let's face it. Shareholders of Geron and ACTC want to make money asap. You can just read these posts every day and see that patience has flown out the window. Instant gratification is the game today in this country. Gotta have it right now. Patience was for the old generation. This company IMO will do great things in the future BUT you have to wait on it. If you have a well rounded portfolio it's really easy. Some of your stocks should have a ripeing of say 6 months, others with a 12 to 18 month timeline and speculative stocks like ACTC, BTIM, ASTM,etc. 2 to 3 years. It is easy really but if you have a 3 to 6 month timeline for ACTC you will no doubt get frustrated if you don't see this "going to the moon". Takes time. Also I hope everyone here realizes that individual retail investors have left the market. Latest mutual fund redemptions of 33 billion that was reported recently proves that. Patience is dictated here folks.

    • Furthermore, it seems they are only injecting one eye.

      • 1 Reply to rumit999
      • Agree. One of the things that really bothers me is that - after meeting with the FDA during pre-clinical activities - ACTC/ Lanza stated that "we have a pretty good idea of what they're looking for". Management-101 says that you understand the approval criteria before you do your work, so you know the yardstick you're going to measured against in advance. So, ACTC spends years on their pre-clinical work, submits the 20,000 page IND, and then - after they submit - the FDA says, "well, you need to do more tests on different animals". WTF. I'm sorry, but that is a major major f-up in my book by ACTC management and the FDA. Did the FDA not tell ACTC back in 2007 during pre-clinicals that there was a good chance they'll require multiple animal models? Even if they didn't, isn't that something ACTC should have anticipated back in 2007/2008 so they could have been doing that work in parallel? I'm long, but will be reevaluating my position if the IND is not approved in September and the FDA comes back with more questions, as it will raise an even bigger red flag that ACTC management does not have their act together. The true knowledgable longs here know that Caldwell has already slipped his timeline for SMD by 1 qtr... he orginally stated trials would start 3rd qtr 2010 with results 4th qtr 2010. Yes, you can argue that some of this is beyond his control, but ACTC management shares the blame of not anticipating / pinning the FDA down during pre-clinicals that multiple animal studies would likely be needed to get SMD IND approval.

    • Super - You're not being insensitive. There is simply no sense of urgency at the FDA & NIH. All this talk of orphan status, fast-tracking, and past articles about the FDA & NIH working together to shorten time to get new drugs/treatments to market... and yet here we sit almost a year after we submitted the IND, which was supported by many many years of pre-clinical work and meetings with the FDA during the pre-clinical activities. It's ridiculous & frustrating. The only positive is that once we are approved, others behind us will likely have similar hoops to jump thru before they are approved. After we're approved, I'm hoping that we'll start to get some updates on what orhpan status, fast-tracking, and the combined Phase I/II timeframes look like... hoping for some good news in terms of projected time for Phase I/II, and when we expect to start Phase III.

    • "faced with the prospect of going blind?"

      Being faced with the "prospect of going blind" is a lot different than actually being blind. Some one in this condition can always get worse and they may not want to try an experimental treatment that might make it worse ...

      • 1 Reply to rathernotthanks
      • So of course rather, you could be counted among those that "faced with the Prospect of going blind" would turn down this experimental treatment, is that correct. My mom went almost completely blind a couple of years prior to passing three years ago. She told me that was the thing that made her want to give up. So I'll side on the experimental treatment side.

    • Most of us here are hoping for a change in the pps when the approval comes from the FDA. Imagine though if you had Stargardt's disease in it's early stages waiting for the trial results, to find out if you have a treatment for your disease. I am thoroughly convinced that there are more than a few outside pressures attempting to keep this tiny trial from going forward. The drug companies don't want Geron, Advanced Cell Technology, or any other stem-cell company to succeed. If this treatment for Stargardt's works then it opens the door for a treatment for Macular Degeneration. There are several major companies with minimally effective treatments for AMD. They don't want someone to step in with a CURE! That is a massive hit. They want everyone in america taking pills.

      I am 57 and currently on no medication. I went in to Philadelphia to get pre-screened for surgery to fix a sinus problem that I have. The nurse there asked me what medications I was on. I told her that I was on none and her jaw nearly hit the floor. She was astounded, and told me that nearly everyone who came in there was on at least one med if not two or three. I looked around and most of the people in there were not 60,70,80 years old, most were in their 30's and 40's. Not tooting my horn about the no meds, but just pointing out that the drug companies are extremely pervasive in our society, way to much so in my opinion.

      I'll take it a step further. I've been to the doctor's office a couple of times in the last few years. He was kind enough to give me some samples for my allergy problem that a sales rep had dropped off. Does this scenario sound familiar to any of you? It's kind of like the neighborhood pusher saying, "The first one's on me!". Look it might sound like I'm bashing doctors as well as the drug companies, that is not the case. The pusher in this scenario is the drug company not the doctor.

    • FDA and NIH are both a complete joke.

      Nothing but a bunch of fat lazy good for-nothings.