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TOPIC: FDA Meeting

FDA Meeting 01 Dec 2017 10:06 #10684

  • franshei
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I think a FDA meeting has been scheduled or being held (as early as today).

There is a case for filing eligibility, (Hedrick has mentioned the reasons). The FDA decision may depend on the need and safety issues, as well as compromised conditions/limitations. Most people believe the FDA would request a phase 3 trial just in diffuse cutaneous scleroderma.

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FDA Meeting 02 Dec 2017 07:35 #10685

  • fas
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Yes- just as a reminder- a phase 3 or better pivotal PMA is what the Company also expects- they provide two options:

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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:

FDA Meeting 02 Dec 2017 12:08 #10686

  • myownhedgefund
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There was someone that got filled for about 400K shares around the $0.325 area
If you look at YAHOO volume it was over 1 million shares but if you look at DOV's (since his name has been recently brought up) naked short site, volume was 316K with over half of that as short volume..

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FDA Meeting 04 Dec 2017 09:07 #10688

  • waddlingwillbologni
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Franshei --

Is this another of your speculative guesses from way far out in left field? Perhaps you can provide some factual context to support your posts in the future?

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FDA Meeting 04 Dec 2017 10:31 #10690

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waddlingwillbologni wrote: Franshei --

Is this another of your speculative guesses from way far out in left field? Perhaps you can provide some factual context to support your posts in the future?


Waddle-

My name is not Franshei- but I would like to remind you, that this Board is all about speculations and not just only facts, otherwise things would become quite boring soon.

Just those speculations should be reasonable- and in my view Franshei´s speculations are reasonable. The facts supporting that are that-


  • 1. Cytori stated in the Q2 call in August that they were almost done completing the complete analysis of the STAR data and could file the meeting material soon
  • .


  • 2. General experience with requesting meetings like that with the FDA and getting a date, tend to require a 3-4 month "being patient" period.

  • I am expecting something in December also- but am not very optimistic as to its outcome.

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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:
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