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Re: fulleroots post# 24186

Wednesday, 09/08/2010 12:22:56 PM

Wednesday, September 08, 2010 12:22:56 PM

Post# of 92948
Don't know why you are banned.. you can try to rejoin I imagine.

Anyway, Caesar posted this on 9/2. I believe it is an email from Dan in which he garnered a response from Mr. Caldwell.

We have emailed Dan this morning to clarify where we are and received this email back from Dan.

Caldwell's response is apropriate from a legal standpoint as it should be. And I like the answer, which to me, means that the FDA has the ball and they are checking everything to make sure that they have covered everthing.

My own sense is still the same... We can have an FDA approval PR
any bright morning in the coming weeks.

Cuenca
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Here is where we are per Caldwell:

Knowing just how valuable your time is, I wanted to share BIll Caldwell's thoughts directly with you.

The FDA has been in dialogue with us since we filed last November. This is a technology platform that is very new and has an extremely high profile publicly. The FDA does not want another Geron situation and thus is going to extremes, appropriately so, to insure that they are comfortable moving forward with this IND. It is their timetable and their comfort level that we are working to satisfy. We are not privy to either other to be responsive to any issues in which they are unclear or need better support. When we have a change in our status that is material you can rest assure we will communicate it publicly. We will not engage in speculation or provide anything publicly that anyway will appear to the FDA that we are applying pressure or lobbying. This is their game, their rules and we will adhere to them appropriately as do most other companies they regulate.

You can be assured that our development team is working hard to move this process forward. We are grateful for your support and will continue to work hard to earn it.

Best,

William M. Caldwell IV

Chairman & CEO

Advanced Cell Technology, Inc

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