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TOPIC: Fordes article on conditional approval

Fordes article on conditional approval 10 Nov 2017 10:26 #10469

  • myownhedgefund
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Article is from may of 2016 but a quick read seems to point that Cytori as a far better shot in Europe that the USA for conditional approval.
We have been feed these carrots before but in the end it will be up to the FDA.
Interesting article:
www.forbes.com/sites/realspin/2016/05/05/the-fda-needs-a-conditional-approval-system/#4e99617c49c7

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Fordes article on conditional approval 10 Nov 2017 12:15 #10471

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I do not think FDA gives conditional NDA or PMA approval in the US.

As I have said, the US FDA could offer an approval with limited claims, based on many considerations. They are not black and white, unless there are obvious safety (particularly death and irreversible toxic events), efficacy and other issues. There is a big section on risks and benefits in the submission. VCEL's cardio phase 2B study has several death and this could be a good reason for the FDA to request a full phase 3 trial. I think the FDA may offer CYTX eligibility for filing, if they have good reasons. As I said, FDA can reject an approval based on their own internal assessment (a collective decision), during the year long careful review. If there is a rejection, it could come very quickly after full submission. Note: pre submission information is often bias.

I think CYTX's consultants should not approach the FDA with a request for PMA filing, unless there is at least a 75% of success.

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Fordes article on conditional approval 10 Nov 2017 12:33 #10472

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Hedge-

The Forbes article makes an argument for the FDA needing an Conditional Approval system and quotes the FDA panel on Eteplirsen, which rejected all Companies requests to approve the product.

Still- surprise, surprise- Eteplirsen got Conditional Approval- link - Sarepta approval

We have also the recent statement of Scott Gottlieb, the new commissioner, which sounds pretty positive to me that they want to do something with adult stem cell technology and who sounded extremely supportive - link FDA Statement

On top of that we have the most extreme safety profile of any therapy or drug around.

I think Hedrick stands a very good chance on conditional approval and a phase 4 and wish him all the luck in the world with it, despite the past and all blunders.

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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:

Fordes article on conditional approval 10 Nov 2017 12:54 #10473

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Sure, these approvals happen...what I took from the article is they are quite rare and the FDA doesn't really like to do them.
That said I know Genentech got one a few years back.
One can scan the FDA's own rules and use their own judgement where we stand.
If it does work it will help at least some patients...so that would be a positive.
FDA links:
www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm313768.htm
and
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf

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Fordes article on conditional approval 10 Nov 2017 18:35 #10476

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BTW FAS
I thought you would have appreciated the author Dr Gulfo and his history with MELA...now SSKN
His history there reads very closely to ours in so many respects.

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Fordes article on conditional approval 12 Nov 2017 09:32 #10481

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myownhedgefund wrote: BTW FAS
I thought you would have appreciated the author Dr Gulfo and his history with MELA...now SSKN
His history there reads very closely to ours in so many respects.


I could almost give you a complete history on that one. Unfortunately, MELA, SSKN is another one I foolishly hooked up with big time! Rode it out for years with them because like Cytori, I liked the machine that I had a personal experience with. Now Gulfo’s baby Melafind has been placed deep into the back shelf because Derms were stubborn in giving up their cash cow biopsies. SSKN new emphasis is XTRAC, a laser machine for the treatment of skin disorders and also hooking up with other laser suppliers for distribution.
Gulfo went through hell with the FDA in getting Melafind approval to the point of Melafind being specifically referenced during a Congressional hearing on FDA approval process for medical device with the FDA head of medical devices admitting during the hearing that mistakes were made on their part for the Melafind approval process.
Hedrick could learn a lot from this man on what he has to offer if he could hire him as a consultant.

www.josephgulfo.com

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Fordes article on conditional approval 12 Nov 2017 12:12 #10482

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b7-

Yeah- I liked the device too and had some MELA shares, even purchased some calls before that decisive FDA meeting, since I thought it was a sure thing. Turned bad because the device did not properly recognize 2-3% of melanoma´s and an FDA bloke said, the device kills people. Despite dermatologists having a much bigger error rate and drugs in general kills hundred thousands of patients....

I know- FDA is quite unpredictable - in both ways.

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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:

Fordes article on conditional approval 12 Nov 2017 16:21 #10483

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My wife and I still see a Derm who purchased the machine from MELA. It caught an atypical mole on myself that my prior Derm had missed for some time. It also saved my wife from two unnecessary cuts that her prior Derm who was a cutter said she needed. PA at the office also told us of a patient who had two questionable moles that they were going to monitor for a while but then decided to use Melafind which showed them to be Melanoma, subsequently validated by biopsies. Needless to say that patient became a huge fan of Melafind.

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Fordes article on conditional approval 12 Nov 2017 22:23 #10484

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***I know- FDA is quite unpredictable - in both ways. ***

On that I will agree Fas
MELA had stat sig data I believe. Cytori missed on STAR as a whole and even the subset was a miss on stat sig.
This is why people assigning a 75% chance or any percent higher or lower as absolutely ludicrous imho.
I don't mind Cytori taking the gamble but lets at least be honest of what it is...then we can hope for the best.

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Fordes article on conditional approval 13 Nov 2017 08:41 #10487

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“MELA had stat sig data I believe”
They did, and that’s the reason why the FDA Chief of Medical Devices had to publicly admit to a Congressional hearing that they made mistakes with MELA’s evaluation.

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