Replies to Post #54656 onTherapeutic Solutions International Inc (TSOI)

Replies to post #54656 on Therapeutic Solutions International Inc (TSOI)

Replies to #54656 on Therapeutic Solutions International Inc (TSOI)

11/04/22 5:39 PM

#54658 RE: tractor4sale #54656

Oh no I won’t be silenced. I’ll just leave this right here. Shady is as shady does.

Questions seem to arise after Dixon's releases & rebuttals

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.

https://forum.therapeuticsolutionsint.com/viewtopic.php?t=268&hilit=check+box&start=75

More questions arose after the questioning public learned there is/was NO box to NOT check to make public the Phase 3 Trials info. Timothy G Dixon attested after saying all paperwork had been submitted & it was their fault for the delays yet when it could be available he was NOT going to check the box to make it public.

https://clinicaltrials.gov/

When will the NCT Number for my study be assigned? ??The NCT Number, also called the ClinicalTrials.gov Identifier, is assigned after the protocol information has been Released (submitted) by the Responsible Party and passed review by ClinicalTrials.gov staff. At that time an e-mail notification containing the NCT Number is sent. The record, including its NCT Number, will typically be available on ClinicalTrials.gov within 2–5 business days after it is Released.

https://clinicaltrials.gov/ct2/manage-recs/faq#:~:text=The%20record%2C%20including%20its%20NCT,days%20after%20it%20is%20Released.
daily ?These data are provided to the National Library of Medicine by organizations and institutions that sponsor and implement the studies. ClinicalTrials.gov is updated daily. You should check ClinicalTrials.gov frequently for updated information.

https://clinicaltrials.gov/ct2/about-site/terms-conditions#:~:text=These%20data%20are%20provided%20to,gov%20frequently%20for%20updated%20information.

Wednesday, October 26, 2022 11:39:49 AM
Post# 54412 of 54620
Re: NEWS 8/25/22
Post by Tempo » Thu Aug 25, 2022 7:09 pm

nirajpdl123 I found this: FDA will review these submissions within 30 days and issue an approval, conditional approval, or disapproval letter. As appropriate, and in accordance with §§ 56.110 and 56.111, changes submitted to FDA for prior approval may also require approval from the participating IRBs prior to implementation.Sep 25, 2018 https://www.fda.gov/regulatory-informat ... y-and-cdrh

Re: NEWS 8/25/22
Since, per the below FDA website, review time for initial IND is 30 days, positive FDA response is expected within the month resulting in potential upward catalyst for the stock price, which is currently near 52 week lows:

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-applications-clinical-investigations-overview

https://forum.therapeuticsolutionsint.com/viewtopic.php?t=340&hilit=expand&start=30

Any can now try to talk it back yet this is what they were pushing/pumping previously

Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.

Expanded Access to Investigational Drugs for Treatment Usehttps://www.fda.gov › media › download ?PDF ?Although there will be a 30-day period for initiation of the new treatment IND or protocol, as required by the regulations, the review division can act sooner ...

Q3: When should an expanded access protocol submission be used? ?A3: An expanded access protocol submission for expanded access should be used only if the ?sponsor seeking expanded access has an existing IND in effect — typically, such a sponsor is a ?commercial sponsor with an existing IND under which the sponsor is developing the drug for ?marketing. When there is an existing IND in effect, FDA generally encourages the submission ?of an expanded access protocol, rather than a new expanded access IND, because having all ?expanded access use and clinical trial use consolidated under a single IND may facilitate ?identification of safety concerns, may make the administrative process less burdensome for ?sponsors and FDA, and may help in product review.

https://www.fda.gov/media/85675/download

my opinion is TSOI will get approval & then this expansion will allow for enough participants to fulfill what is required

Exactly. Why did Tim feel it was necessary to lie. An NCT number is assigned when a study is registered. A trial is not happening if there is no registration. You cannot hide registration. ??If he lied to conceal that it is not happening in the US, I don't see what the big deal is if it is happening in a different country for the time being. That is still good news and would have brought lots of attention and probably helped the stock price too. ??I just cannot wrap my head around what benefit there is to the company and shareholders not to clarify and confirm what is going on. I suppose he cannot correct himself now because he will admit to being a liar. Very disappointing. But we will figure out what happened in the end. It is not like it can be kept secret forever. Just deal with it.