Can Always Ask Tim

This forum is to discuss general things concerning TSOI.
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TimGDixon
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Re: Can Always Ask Tim

Post by TimGDixon »

Cody with all love and respect you are on the wrong tangent. Merck has nothing to do with us - I don't see the "pill" as any kind of competition whatsoever. Listen to me carefully. The Jadicell Phase 3 is not to have an "approved" covid-19 therapy. It is to seek final approval to treat lung disease in the general public - things like COPD, emphysema, bronchitis, asthma, and yes ARDS. Do you know there are hundreds of ARDS cases every single day in the USA that have nothing to do with covid-19? Covid-19 ARDS is merely the vehicle to get there so don't burden yourself worrying about something that isn't even in the same class of drugs (a living drug) as JadiCell.
Codycrusher wrote: Wed Oct 13, 2021 4:47 pm So Tim, I have a concern to share that many shareholders now share and I am not negative and still loading the boat, this has nothing to do with the share price but this is a legit concern.
So there is many businesses working on cures for covid lung damage/ARDS and Merck is 1 of them, they beat us to EUA filing so that feels like they are already ahead of the curve as our competitor, that is not good for our Jadicell covid lung damage/ARDS treatment, I assume there is more pharma and other businesses also working on covid lung damage cures so I think TSOI is on a timeline before we are screwed with our Jadicell for lung damage, any thoughts?
anything to worry about?

Simply put, I am more or less emphasizing on the timeline, it’s been 2 or almost 2 months since TSOI has begun working on jadicell for EUA and we haven’t even begun clinical trials yet, we don’t have unlimited time to get this to market, if it takes 1 year to get clinical trials began for example, that is just an example, we’re gonna be screwed, i am simply sharing my thoughts that I think things need to start, clinical trials need to be started, I feel like and us investors feel like you need to get the money pronto, not wait 2 months or more for the share price to hit .1
because I don’t think that we have time to waste and I think this waiting is going to hurt our science because we have competitors and they are starting to just run past us. It’s like a jog, whoever makes it to the finish line wins, TSOI needs to jog faster.
I only speak for Jadicell covid lung damage/ARDS, I feel and I have the concern along with the majority of investors, we are on a timeline, if things don’t move along at a fast enough pace we are going to miss the bus, our Jadicell for specifically covid lung damage will become useless.
What if Covid goes away in 2 years and a different disease with a different name is a disease we are dealing with than, our Jadicell would have to go through an entire brand new phase 1-2 and 3 for a brand new different named disease for example, there is no guarantee covid will be around in 2 years, or 3 so I think that we are running out of time if clinical trials don’t get started.
I respect you with the Utmost Tim, you are great, I just needed to share my concern.

Respectfully, your loyal investor and friend cody.
Codycrusher
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Re: Can Always Ask Tim

Post by Codycrusher »

Ohhh, ohhh now you got my attention, so I just want to clarify, so your saying that even if covid disappeared, let’s say for example in 3 days covid was no longer around and let’s say that clinical trials were complete for example, You are saying that our Jadicell for covid lung damage/ARDS would still be viable for treating patients as a marketable product continuing after covid because ARDS falls into category’s far beyond Covid and there is so many cases of ARDS not related to covid, so covid or no covid, our Jadicell still would not have to RE Go through the phases again for ARDS and it would still be viable for treating people nationwide with ARDS, I just want clarification because that makes me a lot more at ease about the science, knowing even if no disease than our science still holds value and can still continue to save lives far after and if covid disappears.
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TimGDixon
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Re: Can Always Ask Tim

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I am saying that the end game here is full approval by FDA to be used within the general population with "lung disease" not covid-19 ARDS although that would be included and so would ARDS caused by other things like with pneumonia, inhaling salt water, and other toxic things.

Lung disease includes disease like COPD. There are 16 million Americans who have COPD. There are 65 million humans worldwide who have COPD. All of these are lung diseases: asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, bronchitis, pulmonary fibrosis, sarcoidosis, hypertension, pneumonia, pulmonary edema, pulmonary embolus, influenza.

So to repeat for clarity, the Phase 3 trial, assuming we meet our end-points, is to seek registration of the cell to be used in the general population with lung diseases which includes all of the above.
Codycrusher wrote: Wed Oct 13, 2021 7:00 pm Ohhh, ohhh now you got my attention, so I just want to clarify, so your saying that even if covid disappeared, let’s say for example in 3 days covid was no longer around and let’s say that clinical trials were complete for example, You are saying that our Jadicell for covid lung damage/ARDS would still be viable for treating patients as a marketable product continuing after covid because ARDS falls into category’s far beyond Covid and there is so many cases of ARDS not related to covid, so covid or no covid, our Jadicell still would not have to RE Go through the phases again for ARDS and it would still be viable for treating people nationwide with ARDS, I just want clarification because that makes me a lot more at ease about the science, knowing even if no disease than our science still holds value and can still continue to save lives far after and if covid disappears.
Codycrusher
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Re: Can Always Ask Tim

Post by Codycrusher »

I am so happy, Thankyou so much for the information and I am spreading this info on the investor boards now, AMAZING!!!!! You ROCK Tim!
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TimGDixon
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Re: Can Always Ask Tim

Post by TimGDixon »

Do yourself a favor Cody and review the info on this page: https://bioinformant.com/price-of-cell- ... -products/

JadiCell is an intravenously administered cell therapy, and if approved, it would garner similar fees as prochymal and temcell. The stakes are this big.

Intravenous Cell Therapy

The next most expensive cell therapy products are the ones that are administered intravenously, which range in price from approximately $90,000 to $200,000. For example, Prochymal is an intravenously administered allogenic MSC therapy derived from the bone marrow of adult donors (pricing of $200,000), Provenge is an intravenously administered cancer immunotherapy for prostate cancer ($93,000), and Temcell is an intravenously administered autologous MSC product for the treatment of acute GVHD after an allogeneic bone marrow transplant (pricing of $115,000-170,000).
Codycrusher
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Re: Can Always Ask Tim

Post by Codycrusher »

I figure I’d throw this out there because so many are asking, here is the picture Tim, I wonder if you could possibly provide a good answer to this question.
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TimGDixon
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Re: Can Always Ask Tim

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I am only answering his because tractor4sale asked it - in the future please don't become a messenger for others who have ill will towards us and won't ask themselves tractor4sale is not in that category. Cells for clinical trial are made and cryopreserved. Our future lab will generate cells for use beyond the clinical needs of the phase 3.
Codycrusher
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Re: Can Always Ask Tim

Post by Codycrusher »

Oh I see, thankyou.
Orion1
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Re: Can Always Ask Tim

Post by Orion1 »

So to make sure I am understanding the relevance of Covid 19 role in the jadicell trials. The covid based EUA is a vehicle for additional funding if not complete funding for completion of the trials and possibly manufacturing resources?.. I realize the significant value of jadicell to treat pulmonary diseases beyond covid and there are a significant number of other complications that could be avoided with the early stage treatment of these pulmonary disease processes. I may be crazy or misinformed but jadicells can be used to treat other non-pulmonary systems, right?
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TimGDixon
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Re: Can Always Ask Tim

Post by TimGDixon »

No not really. The EUA that is in front of us is for the same type patient as in the clinical trial. It is not a funding vehicle even though revenue would be generated by their use. Assuming there are profits after the fact, they can be used for any purpose I suppose.

JadiCell has many uses outside of our licensing but we own the rights to the "lung" as an entire organ and for two indications in the brain, CTE and TBI.
Orion1 wrote: Thu Oct 14, 2021 8:21 am So to make sure I am understanding the relevance of Covid 19 role in the jadicell trials. The covid based EUA is a vehicle for additional funding if not complete funding for completion of the trials and possibly manufacturing resources?.. I realize the significant value of jadicell to treat pulmonary diseases beyond covid and there are a significant number of other complications that could be avoided with the early stage treatment of these pulmonary disease processes. I may be crazy or misinformed but jadicells can be used to treat other non-pulmonary systems, right?
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