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Replies to post #58517 on Therapeutic Solutions International Inc (TSOI)
05/15/23 2:05 PM
Post by TimGDixon» Sat Feb 11, 2023 4:58 am
noslippas808 wrote: ?Fri Feb 10, 2023 1:36 pm
i guess everyone want me to ask u about the new 8K just filed... ppl feel its saying TSOI is not in position of any cells to do a phase 3 and so there are no enrollments or patients tested... maybe this be why u havent had to check that box those ppl at ST all seem to want checked?
Good Morning Everyone. I apologize for taking so long to reply but I needed to think about this a little. The 8k and in particular the UM letter is the worst thing I’ve ever had to write. This didn’t begin when the letter was written and sent. We have been requesting this documentation really from the very beginning.Back in April 2022 when we sent the first $200,000 to UM we were to receive a certain number of doses as part of that exchange (I think it was 50) and they were to be delivered to a “drug depot” for trial site distribution and as part of that we requested the associated description of the cell numbers received and characterization documentation, temperature logs, chain of custody logs, and regulatory paperwork including all of the cGMP documentation on the origins of the cells provided by patel to UM. What we got was a second document dump in mid-April of thousands of more pages of data that contained nothing related to what we requested and this has continued right up to present. Needless to say we never got any proof of anything and then the depositions happened and our fears I suppose were confirmed. We now have to go to FDA and seek guidance and until we do that I won’t be speaking much more on this topic or about where we go from here. I know this is upsetting and you have every right to be upset and I can only ask that we take this one step at a time. We still own what we own and no one can take that from us but we didn’t get what we paid for.
In the meantime we still have lots of other projects involving our own 71 patents that are all important as well and perhaps they have been more deserving of recognition than they have received. We really don’t favor one thing over another because these are our inventions and they are like our children. Yeah, the kids are alright.
“...never interrupt your enemy when he is making mistakes...”
https://forum.therapeuticsolutionsint.com/viewtopic.php?t=16&start=1245
https://www.sec.gov/Archives/edgar/data/1419051/000149315223004263/ex99-1.htm
06/20/23 5:29 PM
06/22/23 4:07 PM
JadiCells won't always be JadiCells Post by TimGDixon » Wed Jul 20, 2022 6:17 pm
That's right everything was submitted and is sitting there but hasn't been cleared yet and when it is we're not going to check the box to make it visible. That's what I'm saying.
“...my pathway led by confusion boats, mutiny from stern to bow... Ah, but I was so much older then I’m younger than that now...”
https://forum.therapeuticsolutionsint.com/viewtopic.php?p=18989#p18989
by TimGDixon » Fri May 05, 2023 1:49 pm
what I am saying is intrinsically there is no monetary value to a listing of a clinical trial on a gov website - if there was we would have to account for it and write a footnote disclosure - way too much hype has ben placed on such things when I know as the operator its just not true - doesn't mean the trial isn't of value to investors but just a listing - btw, NIH says they don't stand behind any listing on their sites. we announced a new phase 3 ards and got .003 out of it for a day - its completely arbitrary and artificial - it was just an announcement - I've put out hundreds of "announcements" and you see what they do - nothing. No, what matters is getting through all 128 patients and closing the trial out, publishing the results and filing for a BLA. Then we will celebrate!
08/15/23 3:18 PM
Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant
ClinicalTrials.gov: Home https://clinicaltrials.gov
A structured online system, such as ClinicalTrials.gov, that provides the public with access to summary information about ongoing and completed clinical studies
Purpose of Clinical Trials gov
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.
Re: JadiCells won't always be JadiCells
Post by TimGDixon » Wed Jul 20, 2022 6:17 pm
That's right everything was submitted and is sitting there but hasn't been cleared yet and when it is we're not going to check the box to make it visible. That's what I'm saying.
“...my pathway led by confusion boats, mutiny from stern to bow... Ah, but I was so much older then I’m younger than that now...”
by TimGDixon » Fri May 05, 2023 1:49 pm
what I am saying is intrinsically there is no monetary value to a listing of a clinical trial on a gov website - if there was we would have to account for it and write a footnote disclosure - way too much hype has ben placed on such things when I know as the operator its just not true - doesn't mean the trial isn't of value to investors but just a listing - btw, NIH says they don't stand behind any listing on their sites. we announced a new phase 3 ards and got .003 out of it for a day - its completely arbitrary and artificial - it was just an announcement - I've put out hundreds of "announcements" and you see what they do - nothing. No, what matters is getting through all 128 patients and closing the trial out, publishing the results and filing for a BLA. Then we will celebrate!
