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TOPIC: Dr.Christopher Centeno on Cytori and POC devices

Dr.Christopher Centeno on Cytori and POC devices 20 Feb 2014 04:00 #1339

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Yesterday- we had one of those other "regulatory" discussions at LinkedIn. As expert - called upon, which I really hate. I mean- re-chewing all the same stuff. I bet in a year everybody forgot again and it starts all over. Makes me respect Chris Centeno even more- since he has been repeating his stance against the FDA for five full years, with HEAPS of repetition. :KO:

Anyway- I want to share his view on Cytori and regen med going forward- agrees ONE HUNDRED PERCENT (100%) with MINE

My post: All- based on the present status quo- they simply are in the driver´s seat. As Chris correctly noted - after the decision that Celution would be regulated as a device and NOT an IND, they sued the FDA to get 510K based on predicate device (they used the Harvest machine as predicate). That one did not fly since the US courts do not want to question the knowledge and authority of the FDA (compare to Richard´s notes LOL) so Celution is a Class III device for which clinical trials are needed. Good for Cytori , since the "n´s" are much smaller than with drugs (INDs). Good for CBER since no Company can ever claim 510K predicate device based on Celution. i.e. being significantly similar.

Chris Centeno : Yes, Cytori is in the driver's seat with great technology. In addition, I'm a big believer that POC devices and procedures like Cellution will ultimately win the day for 80% of medical applications and that much more expensive cell-drugs will be used for the minority of issues-mostly areas like cancer, MS, some cardiac, and severe neuro conditions where the higher price point is justified.


Frame the above- this will happen. :nice: :happy:
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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:

Dr.Christopher Centeno on Cytori and POC devices 20 Feb 2014 09:29 #1340

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Thanks for sharing Fas.

On Dr Centeno's comment on "higher price point is justified" indications.

Does he believe this due to the amount of cells available/needed or due to availabile for immediate use. Which in his example for MS makes no sense....so I am guess it the numbers of cells.
In such cases we could give multiple treatments which may prove to be more effective in severe chronic conditions anyway although this would need to be proven and who am I to aguue with a 80% (eighty percent) market to address.

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Dr.Christopher Centeno on Cytori and POC devices 20 Feb 2014 11:08 #1341

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Hedge- I think he does not mean any of the two choices you mention, but in general the high cost of development and the resulting COGS of the highly cultured or engineered off-the-shelf product, which tend to lack of potency.

We have seen it with Revascor and Prochymal- hardly any results but big prices under discussion- 2x 100.000 for GvHD. And Revascor should also be north of 30K. too.

No reason to go in details here really- just the overall thoughts and concepts, which to me are plain common sense.

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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:

Dr.Christopher Centeno on Cytori and POC devices 20 Feb 2014 12:02 #1343

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I understood the culturing pathway results in a high COGS...I just didnt understand why he thought it would be justified in some cases.

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Dr.Christopher Centeno on Cytori and POC devices 20 Feb 2014 13:42 #1346

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Fas, thanks for keeping us in the loop. Very gratifying to have someone like Centeno exhibit such confidence in the Celution device. Certainly helps to sleep at night while holding a position double that which I intended. :yep:

I believe that Cardio, Neurological, MS and autoimmune disease will be successfully treated with ADRC. No doubt technological advancement and knowledge will lead to procedures/drugs/devices that may well superceed Cytori. However, if we take advantage of all the translational studies that are being undertaken, and the fact that devices require smaller trial sizes we can theoretically get first mover advantage in a large number of indications. This is vital as it will raise the bar against which our competitors will be measured.

Our simple cost effective approach will make it very easy for state health bodies and private insurance payors to prefer Celution instead of the over engineered allogeneic alternatives. COGS is going to be paramount. :grin:

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