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Off Topic on Adult (=regenerative) cell technology, but very much related i.e. pills and drugs of which we do not know if they work
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90 minutes 31 Jul 2017 21:33 #9741

  • myownhedgefund
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I guess some still think cardiac is eventually viable in some form.
The real key was acute treatment to prevent chronic disease.
Cytori went for the sickest and we know the result.
I had long given up on Cytori being the one who brought this to market.

This article suggest that the old fashioned stent is still doing well and in record time.

hosted.ap.org/dynamic/stories/U/US_MED_FASTER_HEART_CARE?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT

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90 minutes 01 Aug 2017 09:49 #9742

  • franshei
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Hedge

We should all divide CYTX into 2 businesses and maybe another in between.

1. Cell therapy - s small business in niche markets only. I really think almost all cell therapies (CYTX, CUR, KOOL, ATHX, etc) will not succeed in big therapeutic markets, including cardio, stroke, CNS, etc.

CYTX (cell therapy) will continue to do well in Japan through very specialized, individualized clinics - cell therapies are very tricky, requiring know hows of the treatment and individual medical conditions of the patients. Very difficult to do universal treatments of certain classes of illnesses, as in the case of aspirin for pain and ache.

CYTX (plastic surgery) can do well and CTX 2 will help the business.

CYTX is very, very lucky to find through STAR a therapeutic lead in diffuse cutaneous scleroderma- a very small market (30,000 cases in the US). I do not think CYTX will have a partner for this very small market. I also think the FDA will require another phase 3 for PMA, even if scleradec 2 is positive as scleradec 1. In view of the company's current finance, I think this new phase 3 trail will be delayed, but not cancelled (till there is money). I consider this possibility a good strategy.

If scleradec 2 is positive, CYTX would go for EU approval. During this time, additional STAR followup data should be positive for diffuse cutaneous sceleroderma. myTomorrows will do the EU sales and marketing.

If the detail STAR data analysis indicates that in diffuse cutaneous scleroderma patients, efficacy in the Raynaud's is evident. I think CYTX would go for an IDE (IV uses) for this indication - the study duration should be half that of a new STAR Phase 3 in diffuse cutaneous scleroderma. I think this is the bridge studay Jason is referring to. The cost for this study is very, very small.

In the space of cell therapy, CYTX has 2 ongoing studies in Japan.We shall learn more.

Hedrick is working on a secret project: regenerative nanomedicines. We should hear more.

CYTX liposomal cancer drugs have their own life. This is big business. We should hear more. Lapointe and Martelli and John Harris are really the drivers here. We should have a EU partner for ATI 918.

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90 minutes 01 Aug 2017 10:24 #9743

  • myownhedgefund
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Some good points franshei.

***the study duration should be half that of a new STAR Phase 3 in diffuse cutaneous scleroderma. I think this is the bridge study Jason is referring to. The cost for this study is very, very small.***

By this do you mean a smaller number of patients in the trial or total observational time period ?

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90 minutes 01 Aug 2017 10:56 #9747

  • b767cpt
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"the study duration should be half that of a new STAR Phase 3 "

Sounds to me like he's talking in terms of time at a very small cost, which sounds good to me.

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