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TOPIC: FDA required

FDA required 28 Aug 2013 12:03 #800

  • myownhedgefund
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So it seems ATHENA 2 was FDA required in order to have a chance move forward to a pivitol.

It also seems we have no choice but to partner cardiac to run a pivitol. No choice means little leverage (as always)

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FDA required 28 Aug 2013 13:54 #801

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So it seems ATHENA 2 was FDA required in order to have a chance move forward to a pivitol.


Yes- that was to be expected- as written before- that is is typical FDA=pill experience/attitude. Dose escalation is almost a must with them

I was very surprised that there are 8 EIGHT private investigator studies in the cardiovascular area (late stage) - that is exclusive Cytori themselves. Makes sense that ADVANCE is not concluded since it surely is covered by private (government?) initiative.

I thought I heard a commercial clinic in Australia on cardiac will open? Like Okyanos? Did anybody pick that up too?
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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 required 28 Aug 2013 14:04 #802

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I did see the 8 cardiology trials...in fact that whole slide was the best in the presentation.

While on the face the 8 trials seems good...we have dew registry details that they would fall into ...so is 8 great, good or just a start.
With the usual lack of detail abd managements history of failures re-do's ect. can we really read it as a big positive ? :bash:

Also seems cardiology as a stand alone for Cytori is basically history and they will need a partner to carry it thru....now here would be a positive as it should have real value to a partner and it gets a important program out of CYTX managements hands !!!! Assuming all goes well of course.

Any other thoughts Fas ?

For me it was more dismal than positive on most fronts.

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FDA required 29 Aug 2013 09:17 #805

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Hedge- just general thoughts really.

It was a bit like old times- no Dean with his eloquent speech livening up the "show"- just now Rickey who was following the boring "rules" of an ASM with a presentation added by Calhoun. That presentation was as usual, since no new things were in there, but not bad either. To me it was not comparable to the last CC which was really bad because of the bad answers. This was just neutral to with the unmistakable trend to put more information out on the private investigator trials, which to me is where the value for Cytori is, which the Street simply does not understand.

Government funding of trials in Germany, UK, France, Switzerland, Japan and US. Folks- believe me- this is disruptive tech . Governments nowadays, cannot afford to waste money and do not start clinics without proof of feasibility. This is unique in the world of medicine and as such will prevail. :vegas:
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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 required 29 Aug 2013 11:08 #809

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Thanks for the additional comments Fas...I would add that Tommy Thompson did bail out CC imho as he was rambling about BARDA.

I would like to add one additional perspective that you brought up....that being government trial funding and CYTX valuation. We may be experiencing a cultural difference here. In the US millions upon millions is handed out to small companies to do research and small trials...in means little here and most companies end up with nothing to show for it. This could very well be why many institutions put little value on this even though Cytori has tried to stress its importance.

Elsewhere in the world perhaps it carries more weight...but when I look at the institutional holdings each quarter...I see a few forgein holders but most of them have been traders,,,so it appears even forgein institutions are looking for more solid results. Results that Cytori never likes to disclose.

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