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TOPIC: Regulatory successes and next steps

Regulatory successes and next steps 16 Feb 2014 11:20 #1329

  • fas
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The thread on the China poll gave me at least the conviction that the "educated" readers of this site are thinking like me.

Actually I think it would be rather silly to expect in the world of medicine to get anything "for free"- i.e. approvals without having done clinical studies.

The thread also brought back the focus that Cytori Cell Therapy is regulated according to the device pathway, without any exception anywhere in the world

Personally - when I think back to the answers Tom Baker gave to our boards questions 6 months ago or so- it dawned very heavy on me, that most leading countries are very "ego-centric" in respect of wanting data from their own territory before giving "nods". Just countries like the Philippines and the like without advanced legislation in the field rely heavily on foreign authorities.

The BIG BIG question in my mind- going forward is - will BIG Pharma become partners in commercializing the achieved approvals or is the technology of Cytori that much DISRUPTIVE to them that they simply balk at the tech and Calhoun & Co have to find PRIVATE CAPITAL to help him "conquer the regenerative world".

It looks a bit like the last version at this point in time. I think we will soon know when some deal comes in respect of ortho/sports medicine.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Regulatory successes and next steps 16 Feb 2014 12:00 #1330

  • myownhedgefund
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I completely agree and feel we are far from solving our money issues !!!
In 2014, BARDA money and warrant exercises may extend the runway but still not get us to where we need to be... so either more partners or more secondaries will be needed. Given Cytori's monetary condition one would hope they have someone in mind for the hamstring/sportsmedecine application. CC did mention partnership to bring it fully to market.

For the "ego-centric" aspect of countries I see 2 plausible considerations:

1. Running home trials brings in some cash for the country (even though usually small amount in country terms) and thus tax dollars. Many of the people in regulatory bodies also have research backgrounds and "throwing them a bone" keeps the system alive.

2. Running even a small trial in ones own country also ensures that for some reason a aspect of their specific population for some strange reason doest have issues with a drug or product. In our case while we all have the same biological genome perhaps the issue would be with celase or some populations are more prone to say some specific disease process that they are worried may have a adverse effect. Maybe a kind of silly idea but it certainly covers a reg. bodies butt saying we even ran testing HERE...BEFORE approval.

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