Rocky,
I was concerned in November that the delay in approval of the Stargardt's IND was perhaps related to the very issue. I emailed Dan. The following is the email trail.
Sent: Monday, November 15, 2010 10:45 AM
To: Dan Schustack
Subject: ACTC
Dan,
Good afternoon. Do you know, or could you please find out if the ACTC IND for Stargardt’s is considered a Pediatric IND by the FDA?
Please advise.
Best regards,
From: Dan Schustack [mailto:dschustack@ceocast.com]
Sent: Monday, November 15, 2010 2:24 PM
To: XXXXXXXX
Subject: RE: ACTC
XXXXXXXX:
I would need to find that out from ACT.
However, I can tell that in the several years that I've taken questions, you are the first person to use the word "Pediatric" to me in this, or any other context.
When I find out from ACT, I'll let you know.
We appreciate your interest.
Regards,
Dan
Sent: Monday, November 15, 2010 12:40 PM
To: Dan Schustack
Subject: RE: ACTC
Thanks Dan,
At least I gave you a different question than the same old ones you’ve probably been getting for a while now! The background to the question comes from the fact that Stargardt’s is basically a childhood indication. I have read that the FDA has a greater emphasis on maintaining the integrity of the protocol for these indications. I am just curious if the FDA has given ACTC those requirements since the onset can occur in pediatric years.
I look forward to hearing from you. Thanks for your help!
Best regards,
XXXXXXXXXX:
Your question was quite reasonable, given what I read about Stargardt's being an early onset indication. It was definitely a first and those questions always make any job more interesting. However, in my experience, it is probable that a "first question" will be asked again. And again.
For this reason, I relayed it to Bill Caldwell who answered with a categorical "no". We appreciate your interest and will always keep you as informed as possible within a context of maintaining confidentiality and I.P. estate security. Of course, the next person who asks the question (and there will almost certainly be a "next person") will get an immediate answer from me and I won't have to take Bill's time to do it. Freeing him to do his job uninterrupted until I get my next "first question".
Regards,
Dan
