I got an email from Gail Naughton regarding Histogen Trials

Here was here response to my question about the time frame.

Dear Khalil,

Thanks for your patience.

We are starting phase 1/2 in Singapore before the end of May and hope to have phase 3 pan-Asian data by Sept 2012 for an NDA submission and 2013 approval. (hopefull Q2 2013).

We will be starting to collect info on volunteers shortly.

Please write me in May for an update.

Thanks and take care,

Gail

Thats interesting. It suggests that to go from phase 1 to the end of phase 3 will take a little over a year. That is a very optimisitic timeframe compared to others. I think Aderans phase 3 alone will take just over a year. Perhaps Spencer can ask the question to Craig Ziering if he has him on the show.

Anyway full credit to them if they have something viable.

Quote:

---

Originally Posted by Westonci

Here was here response to my question about the time frame.

Dear Khalil,

Thanks for your patience.

We are starting phase 1/2 in Singapore before the end of May and hope to have phase 3 pan-Asian data by Sept 2012 for an NDA submission and 2013 approval. (hopefull Q2 2013).

We will be starting to collect info on volunteers shortly.

Please write me in May for an update.

Thanks and take care,

Gail

---

Did you get round to writing an email for Gail?

Hey Westonci

I'd be really interested to know what Gail has to say about the timeline now. In her email she said you should write to her for an update in May, did you do this or have you done it since? I really think everyone would be interested in more info from Gail herself, maybe she'll tell us if they've enrolled all the test subjects yet. If you don't have time to email her I'd be happy to do it if you give me her email address.

Yes i have, it should take about a 1 month for a reply.

Ok, thanks for letting me know. Eileen from Histogen answered me about phase I/II trails back in May and she did say there should be an update around the end of June or start of July so that might be similar to what you get back from Gail then.