Next Steps for Jadi

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TimGDixon
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Joined: Fri Jun 26, 2020 4:36 am

Next Steps for Jadi

Post by TimGDixon »

I hope you all slept well with visions of sugar plum fairies dancing in your heads.. i did. So what are our next steps?

First things first we need funding and we are going to seek gov funding before anything else - doesn't mean we will get it but we will avoid dilution here as best we can and its not even on my mind today (dilution). They set aside big money for this very thing and if we don't meet the requirements, who does?

As I said yesterday somewhere down the line, everything is in its proper place. Doses are made and cryofrozen and ready to go - clinical sites have been selected, PI is in place, CRO, and all we need to do is fund it. Its an awesome problem to have.

In the meantime we will begin exploring EUA not only in the USA but worldwide - we can save countless lives on a grand scale if we can get the support we need. One EUA deal and the rest will fall like domino's and we will serve humanity and we will serve you - this is where Pharma comes in - they could partner with us now and help provide all the CMC (chemistry, manufacturing, control) we will need to employ to treat a world full of very sick people. It will take a massive amount of material but healthy termed babies are born all day and night in every city - keep making babies and we'll do just fine :-). We can harvest approximately one trillion jadi cells per umbilical cord - thats enough to give 5,000 people 2 doses of 100 million cells each.

The highway is alive tonight and everybody knows where it goes...i'm feeling like tom morello is playin' today you guys... electrified...


Codycrusher
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Re: Next Steps for Jadi

Post by Codycrusher »

I fall in love with this company more and more over time, this is a really fantastic Bio, there is no biotech out there in the unique position to have a massive future like TSOI, this company is the goose that layed the golden egg, I am going to be here for a long time, I am not budging I love this company, I won’t sell at a low SP either, it would have to hit 5-10 dollars for me to sell some shares. LOVE THIS COMPANY and I love the work you are doing Tim, you have my full support and confidence in you and the company.
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TimGDixon
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Re: Next Steps for Jadi

Post by TimGDixon »

Thanks Cody - you are a super supporter of TSOI and its not gone unnoticed by myself or countless others - thank you. I read about a lot of dreams our crew has and its awesome and i hope we can fulfill all of them - everyone needs to stay parked and locked if you can - you know those contests where you have to keep your hand or something touching to the car and last person standing wins - if you all keep your hand on my car you all win and i;ll fulfill your wildest dreams - its a good problem for me to have - keeps me motivated and forward moving - the plowmen that dig my earth only have straight lines if they never look back, but the ones who have, their plowline is crooked... stay the course.


Codycrusher
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Re: Next Steps for Jadi

Post by Codycrusher »

So Tim, I read you are going to be applying for EUA, will that speed up your phase 3 process and also, will that make it possible to start treating patients almost right away or I’m just wondering what opportunities that will open. Also, When do you plan on applying for EUA, Emergency Use Act, what is a general idea on how long it takes for the government to give a answer, yes or no or whatever and what is the process involving getting an EUA.
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TimGDixon
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Re: Next Steps for Jadi

Post by TimGDixon »

Yes Cody we will seek EUA from FDA under current pandemic criteria as outlined below. I can't give you a window of time here yet but we can do this at the same time we are conducting phase 3. In the USA we have to seel approval by the FDA. Outside the USA, those nations regulatory bodies must also approve their use and they typically follow FDA/NIH. So give us some time here and realize this is big league stuffthat requires lots of attention to detail and lots of paperwork.

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense.

Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below.

Drug and Biological Therapeutic Products
The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table below this blue box.

Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (February 4, 2020) - https://www.federalregister.gov/documen ... -emergency

Emergency Use Authorization Declaration (March 27, 2020)
https://www.federalregister.gov/documen ... eclaration
retsehc
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Re: Next Steps for Jadi

Post by retsehc »

Hi Tim!

I'm checking out the phase II trial at https://clinicaltrials.gov/ct2/show/NCT04355728.
I see it took them almost 4 months to enroll just 24 patients (judging off when recruitment status changed) :o
Obviously that was early pandemic before the nasty winter, delta, vaccine developments, and may other factors. Also, maybe public sentiment regarding stem cells may have played a part. Just wondering if you guys think there will be any difficulty enrolling the 240 patients once recruitment starts. With the previous results on record now I feel like people will be rushing to get in line and the trial will fill up in a couple weeks :D
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TimGDixon
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Re: Next Steps for Jadi

Post by TimGDixon »

Hey Retsehc - yeah it was a little difficult early on because no one really knew what we were dealing with here - but we do now and i don't think we will have any difficulty filling the rolls. A new "variant" is now going to take over the old variant and this is likely a pattern that will persist for some time - but we won't get fooled again - meet the new boss, he's the same as the old bosssssss.


Madadamus
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Re: Next Steps for Jadi

Post by Madadamus »

So what about for CTE? Any more details aside from the PR?
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TimGDixon
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Re: Next Steps for Jadi

Post by TimGDixon »

Good question. We are still preparing the data to send to FDA formally and once we do that there will begin again a review process. The difference here is that Jadi's are already cleared for Phase 3, whereas they weren't when we first filed IND. We have full access to the DMF (drug master file) and everything about Jadi FDA could want to know is contained in the DMF already to the stage where lung use is phase 3. This is why we are pushing hard now to get this done on the heels of the other - you know, strike while the irons hot.
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