Happy Memorial Day

This forum is to discuss general things concerning TSOI.
retsehc
Posts: 27
Joined: Thu Aug 20, 2020 2:41 pm

Re: Happy Memorial Day

Post by retsehc »

Great, Tim!
Some folks are saying FDA now has 30 more days to respond. Is that the case? Or is it an unknown timeline at this point?
Morabry
Posts: 9
Joined: Sat Jan 23, 2021 1:50 pm

Re: Happy Memorial Day

Post by Morabry »

Hi Tim,

Happy to have you back in California - I spent Memorial Day weekend in San Diego.

Question:

Is it pretty standard procedure to go through several rounds of questions when dealing with the FDA? Just curious.
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TimGDixon
Posts: 1189
Joined: Fri Jun 26, 2020 4:36 am

Re: Happy Memorial Day

Post by TimGDixon »

No we are not on a regulatory time clock at this stage nor are we on "clinical hold" - these are precedence level rounds of questions we have been responding to, meaning there are two other co's that got clearance for phase 3 and FDA is using the same questions for us - nothing more and nothing new but rather the same level of questions they asked our predecessors which the regulations let them do but what they can't do is ask us for more than they asked of them. So we patiently wait. I wish i could share with you the detail and dat but its trade secret and proprietary in nature.
retsehc wrote: Thu Jun 03, 2021 8:13 am Great, Tim!
Some folks are saying FDA now has 30 more days to respond. Is that the case? Or is it an unknown timeline at this point?
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TimGDixon
Posts: 1189
Joined: Fri Jun 26, 2020 4:36 am

Re: Happy Memorial Day

Post by TimGDixon »

I hope my response to retsehc covered your Q's.
Morabry wrote: Thu Jun 03, 2021 6:59 pm Hi Tim,

Happy to have you back in California - I spent Memorial Day weekend in San Diego.

Question:

Is it pretty standard procedure to go through several rounds of questions when dealing with the FDA? Just curious.
Codycrusher
Posts: 85
Joined: Sat Feb 13, 2021 2:29 pm

Re: Happy Memorial Day

Post by Codycrusher »

I love what you said Tim, so basically like emailing a normal person but in this case the FDA, the FDA doesn’t have a 30 day timeline, they could respond back to you within 3 days or 7 days or a lot sooner, that is great news. And since we’re on 7 rounds and they have been answered, this makes us very close I assume to being done with the rounds, let’s hope this is it.
You rock Tim! We have faith in you and I also look forward to seeing Stemcells go to clinical trials, that is another excitement us investors are looking forward to, especially phase 3 Jadicell, that will rock!
Us investors hope you search and try to get a 20-25 billion dollar deal once Jadicell is phase 3 approved, if you do that this company’s future will become massive.
There is so many more endeavors you could fund with that sort of funding.
retsehc
Posts: 27
Joined: Thu Aug 20, 2020 2:41 pm

Re: Happy Memorial Day

Post by retsehc »

Thanks for clearing that up, Tim. Glad you had some relaxing time away and glad you’re back.
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