Welcome, Guest
Username: Password: Remember me
The Company
  • Page:
  • 1

TOPIC: SME Status granted by EMA

SME Status granted by EMA 23 Mar 2016 06:05 #6689

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3269
  • Thank you received: 1109
Cytori Granted SME Status by European Medicines Agency

03/23/2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that the European Medicines Agency’s (EMA) Micro, Small and Medium-sized Enterprise (SME) office has granted SME status to Cytori Therapeutics. The newly granted SME status allows Cytori to participate in significant financial incentives, fee reductions, and fee waivers for selective EMA regulatory filings.

The primary aim of the SME initiative is to promote innovation and the development of new medicinal products by smaller companies. To achieve this, incentives are provided to help SMEs overcome the main financial and administrative hurdles associated with pre-marketing procedures, particularly scientific advice, marketing authorization application and inspection procedures.

Financial incentives for SME companies include a 90% fee reduction for scientific advice and quality inspections of facilities along with fee deferrals. SME companies are also eligible to obtain EMA certification of quality and manufacturing data prior to review of clinical data. Other financial incentives include EMA-provided translational services of all regulatory documents required for market authorization, further reducing the financial burden of the market authorization process. Details can be found on the European Medicines Agency website.

“Our SME status could not have come at a more opportune time as we prepare to engage with the EMA for discussions regarding our lead development program for impaired hand function from scleroderma. Incentives provided, including reductions in regulatory fees will result in significant savings, which will help to bolster our cash management activities,” stated Tiago Girao, CFO of Cytori Therapeutics. “More importantly, Cytori is dedicated to commercializing a treatment for scleroderma patients. This SME designation will help us drive towards that objective.”

Cytori is currently working with Idis Managed Access, part of the Clinigen Group plc, to establish a Managed Access Program in select countries across Europe, the Middle East, and Africa for patients with impaired hand function from scleroderma. A MAP will allow Cytori, upon completion of the statutory legal and regulatory requirements, to offer patients and their healthcare providers access to Cytori Cell Therapy™, known as ECCS-50, in advance of the product’s full marketing authorization in their respective countries.

In Europe, the scleroderma affected population appears to be between 31/million and 277/million, which would account for a market size of 17,000 to 149,000 scleroderma patients.1 Additionally, scleroderma is estimated to have a prevalence of 184/million which equates to approximately 45,000 scleroderma affected people in the United States.2

Please Log in or Create an account to join the conversation.

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:

SME Status granted by EMA 23 Mar 2016 06:32 #6690

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3269
  • Thank you received: 1109
I am sure the market i.e. Wallstreet has no clue what to think of this announcement, but I think it is pretty important and has probably some far reaching consequences...

First of all- it becomes attractive to market the application on its own, but does not have to. In my opinion it strengthens Cytori´s negotiation situation with a financially strong partner.

Anyway- it explains also somewhat what the drive or strategy adopted is in Europe from a regulatory perspective. At the time Cytori was preparing for ADVANCE to roll out in Europe, apparently they encountered heaps of issues with the different Competent Authorities in the EU countries, which all had their different requirements since device approvals i.e. CE claims on devices are not centrally dealt with.

Drugs however are centrally dealt with and also relatively parallel to the regulations in the US with CBER for Biological cells and tissues, the EMA also established different EMA institutions- about 5 if I recall right- and one was for cells and tissues.

Actually I was pretty amazed how "few patients" were treated by Tigenix to get their EMEA approval for Chondroselect- the first stem cell product on the market in Europe- back in 2011 it was I believe and also the support they got.

Anyway- together with CE approvals for the equipment - Cytori must believe it makes more sense from a reimbursement perspective to drive "smaller" applications through the EMEA cells and tissues office than knock on the doors of surgeons to sell their Celution units and disposables to them. Over the EMEA one is assured of reimbursement of all "attached" nations, which is simpler than dealing with 30 national institutions and the SME status really seem to help.

Congrats to the team at Callan Road- this is good news and a achievement, which is appreciated (at least by myself :grin: )
The following user(s) said Thank You: Joncon63

Please Log in or Create an account to join the conversation.

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:

SME Status granted by EMA 23 Mar 2016 07:50 #6692

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3269
  • Thank you received: 1109

fas wrote: Cytori Granted SME Status by European Medicines Agency

03/23/2016


Financial incentives for SME companies include a 90% fee reduction for scientific advice and quality inspections of facilities along with fee deferrals. SME companies are also eligible to obtain EMA certification of quality and manufacturing data prior to review of clinical data. Other financial incentives include EMA-provided translational services of all regulatory documents required for market authorization, further reducing the financial burden of the market authorization process. Details can be found on the European Medicines Agency website.


In the announcement a link was buried to an EMA document which specifically detailed some of the cost of applying for Market Authorisation - since one can overlook that- if you browse through this, you will realize quite some costs will be saved with an SME status- not only for scleroderma, but I presume fistula after Crohn´s will go through there again as well as some ortho apps which are driven by Cugat... :yep: :whistle:


File Attachment:

File Name: EMA-NoteOnFeesPayable.pdf
File Size: 754 KB
Attachments:
The following user(s) said Thank You: mtpinman

Please Log in or Create an account to join the conversation.

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:

SME Status granted by EMA 23 Mar 2016 11:09 #6693

  • rothco619
  • rothco619's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 467
  • Thank you received: 67
The following user(s) said Thank You: mtpinman

Please Log in or Create an account to join the conversation.

SME Status granted by EMA 23 Mar 2016 12:09 #6694

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3269
  • Thank you received: 1109
Thanks -with profitability projected now in 2018 by Cytori, it becomes interesting to see how everybody is seeing this panning out...

I have been copying and cutting in Jason´s spreadsheet to make his version legible for us here at the Lodge- see below-




Interesting- little (3 Mio 2016) to no BARDA re-charges projected- after 2016 and main revenues coming from SUI in Japan. I think PAD could be earlier than SUI, but who knows- time will tell. :winky: Jason sees a whole lot of burns app revenue in the US AND Europe already in 2019- :whistle: :whistle: -he might know more than we do?????
Attachments:
The following user(s) said Thank You: mtpinman, d9dozrman

Please Log in or Create an account to join the conversation.

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:

SME Status granted by EMA 23 Mar 2016 14:22 #6695

  • d9dozrman
  • d9dozrman's Avatar
  • Offline
  • Expert Boarder
  • Expert Boarder
  • Posts: 151
  • Thank you received: 21
***Jason sees a whole lot of burns app revenue in the US AND Europe already in 2019- :whistle: :whistle: -he might know more than we do?????***

There once was a lot of hype & hope for the thermal burn app. Maybe that BARDA bridge wasn't burned after Tommy's departure :cool:

d9

Please Log in or Create an account to join the conversation.

SME Status granted by EMA 23 Mar 2016 14:52 #6696

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3269
  • Thank you received: 1109

d9dozrman wrote: ***Jason sees a whole lot of burns app revenue in the US AND Europe already in 2019- :whistle: :whistle: -he might know more than we do?????***

There once was a lot of hype & hope for the thermal burn app. Maybe that BARDA bridge wasn't burned after Tommy's departure :cool:

d9


I do not think that bridge is/was burned- the development is simply very slow for some reason. :whistle:

Anyway- maybe the US is not so much of a surprise- but feels like a bit optimistic for 2019- the thing that surprises is the EU- with the revenue numbers being 125% over the US ones- that can only work if they put the wound healing app through the EMEA in a similar fashion as with scleroderma, but that must happen fast and probably with a partner, since cytori does not have the dough :yep:

As we remember from several slides from the past (2013 mainly)- there were plenty of PI investigations ongoing in Europe - 23 !!!!! - and several were in the wound arena , which could serve as phase II clinics....

Please Log in or Create an account to join the conversation.

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:

SME Status granted by EMA 23 Mar 2016 15:51 #6697

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2742
  • Thank you received: 199
:grin:
My side hurts from laughing !!!!!!!!!!!!!!
Are we even remotely considering revenue forecast from JK ?
He cant even get the share count right....looks like he is using 165 million ! :KO:

SUI trial taking forever just to enroll 45 patients but then a massive acceptance and revenue spike ?
Remember, even when reimbursement comes the patient has to pay 30% of cost out of pocket !!!

Burn revenue also seems out of whack from my perspective.

Cytori guides break even
JK at $0.68
DOV...soon to be announced

BTW...rothco, the link you provided didn't work for me.

Please Log in or Create an account to join the conversation.

SME Status granted by EMA 24 Mar 2016 06:03 #6698

  • rothco619
  • rothco619's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 467
  • Thank you received: 67
Back to kindergarten Hedge cut, paste, click

Please Log in or Create an account to join the conversation.

SME Status granted by EMA 24 Mar 2016 07:34 #6700

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2742
  • Thank you received: 199
LOL rothco
Too late ...already worked for me earlier this morning.
Tried twice yesterday...kept getting page not found or something like that.
Maybe site had a temporary issue...who knows

Please Log in or Create an account to join the conversation.

SME Status granted by EMA 24 Mar 2016 10:19 #6705

  • d9dozrman
  • d9dozrman's Avatar
  • Offline
  • Expert Boarder
  • Expert Boarder
  • Posts: 151
  • Thank you received: 21
hedge, I had the same issue on the second try, however I was able to get in the first time I pasted the link. No doubt a site issue.

d9

Please Log in or Create an account to join the conversation.

SME Status granted by EMA 24 Mar 2016 11:33 #6706

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3269
  • Thank you received: 1109
Adding a file is really not all that difficult.. :whistle:


File Attachment:

File Name: Maxims-report-03-23-16.pdf
File Size: 243 KB
Attachments:

Please Log in or Create an account to join the conversation.

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:

SME Status granted by EMA 24 Mar 2016 15:52 #6708

  • Old Young Fox
  • Old Young Fox's Avatar
  • Offline
  • Expert Boarder
  • Expert Boarder
  • Posts: 101
  • Thank you received: 12
+11% --- with 7 Mio shares -- could break out

regards holdi

Please Log in or Create an account to join the conversation.

holdi

SME Status granted by EMA 25 Mar 2016 09:45 #6711

  • DOV
  • DOV's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 347
  • Thank you received: 194
It is hard to believe all the mistakes and omissions found in Jason Kolbert's financial projections. His quarterly numbers in 2016 do not add up correctly for the year-end totals. He has BARDA revenue dropping to $3 million this year and ending all together after that. His share count numbers are completely wrong. There are some improvements with his format as he has broken down revenues by therapy and region, but he has it all wrong (sounds like we all agree with that).

I should have my numbers ready to post next week. Bad weather and flight delays postponed my "channel checks" yesterday. At this point, I can share that my 2020 projection for SUI in Japan is $4.5 million versus Jason's $363.177 million. Another major is that I have no revenue attributed to thermal burns in the EU in 2020 where he has $143.5 million.

Very much subject to change, my 2018 EPS estimate is $.08 and my 2019E is $.68 and my 2020E is $1.38. I do not go out any farther than 2020 yet.
The following user(s) said Thank You: mtpinman

Please Log in or Create an account to join the conversation.

SME Status granted by EMA 25 Mar 2016 10:02 #6713

  • cytxer
  • cytxer's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 347
  • Thank you received: 25
You cannot blame him, since EVERY BODY keeps changing the estimates and spreadsheets start to fall apart... (you have done it)


***
Very much subject to change, my 2018 EPS estimate is $.08 and my 2019E is $.68 and my 2020E is $1.38. I do not go out any farther than 2020 yet***


I bet these numbers are very, very, very optimistic and you will change your numbers again (like you have in the past several years)

:vegas:

Please Log in or Create an account to join the conversation.

SME Status granted by EMA 25 Mar 2016 10:31 #6714

  • DOV
  • DOV's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 347
  • Thank you received: 194
Fas wrote:
I am sure the market i.e. Wallstreet has no clue what to think of this announcement, but I think it is pretty important and has probably some far reaching consequences...

I would like to add my two sense to what Fas has said here. My first thought after reading this announcement was that the probability of EU approval and reimbursement has gone way up to the point that investors should look at it as a given. Since the market i.e. Wall Street has placed no value on Cytori's therapies ever being reimbursed, there should now be a change (at least in the EU approval). The question is when. The grant itself is designed to speed up the "when" as well as to make it cheaper to accomplish throughout the EU. Jason has a 2020 projection of $100 million and my preliminary number is $125 million so not so far off. Wall Street needs to begin to calculate a discounted net present value of this future revenue. It is worth roughly $.28 in EPS in 2020. Discounted back at 25% annually, I get current earnings of $.09 x a 30 PE ratio puts the current fair market value of EU reimbursement at $2.65 per share. That is a big difference from $.215 at Thursday's close. This difference can only be attributed to management's legacy.

Thursday's update on the STAR Trial was far less significant than Wednesday's news, but it generated 7 million in trading volume versus only 1.3 million. The STAR update stated all 20 sites are up and enrolling with only 40 patients left in the trial. On average each site should treat two patients over the next three months to get to the "mid-year" projected completion date. At this point, safety has been demonstrated over and over again and in my mind is a given. Thursday's announcement provided no new information. But, it goes to show that anything happening in the USA is more important than things happening in the EU or Japan.

Please Log in or Create an account to join the conversation.

SME Status granted by EMA 25 Mar 2016 10:36 #6715

  • DOV
  • DOV's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 347
  • Thank you received: 194
I change my numbers when new information surfaces. There has never been any information that would lead to SUI revenues in Japan of that magnitude.

Please Log in or Create an account to join the conversation.

SME Status granted by EMA 25 Mar 2016 12:40 #6716

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3269
  • Thank you received: 1109

DOV wrote: I change my numbers when new information surfaces. There has never been any information that would lead to SUI revenues in Japan of that magnitude.


I know...I know...but there is a lot of information which has not been shared surely.about Japan, despite the update on strategy and the introduction of the new guru Harris... remember this (all from my article "Abe regenerative law passes in Japan") .. link : HERE

Hedrick: We're actually the only American company that's on the regenerative medicine industry group. So we have a seat at the table with MHLW and the Ministry of Economic Transport as this stuff is debated and then we are – as part of that discussion, we're planning on a go-forward basis on how to respond, but we really won't know exactly what this means probably for a few more months into 2015 and beyond.

Dave Musket: Thanks, Marc, that's very helpful. I guess, the – my presumption before all of this effort was that you already met basically the regs to go forward there. You, obviously have several IFPs ongoing and that with the results of those trials kind of being announced over the next 12 months or so, I think some of them, might be even next quarter, that might actually give you much higher profile for – and might push this agenda a little bit more rapidly. In other words, I'm not sure why a company, a potential partner would need to wait because it doesn't look like you would not qualify under the – any of the guidelines that are being discussed. In fact, it looks like you've already met all those requirements.

Hedrick: The second thing that you really mentioned is, okay, we've got nine or so studies going on, can we take those and convert those into approvals by either taking that data or adding a few more patients and getting formal approval and begin to market it although without reimbursement for that and then set up post-market surveillance studies based on that and then get reimbursement later. And the answer is we absolutely have that as part of our strategy. And if you look at MHLW, the Ministry of Economics and Transport on data, they think that this legislation will cut clinical trial costs in regenerative medicine down by 30%. We probably see more because we hope we're going to be on the lower tier.
And then in the background, we have things that are going on irrespective of this new law, for example, as you know, we have a urology trial that's going, it's multi-center led by Nagoya, which would be geared towards not just early approval, but approval and reimbursement. And so, we're still moving forward on a pathway and we'll talk more about over the next quarter or two to have our own approved and reimbursed technology for specific indications in Japan outside of whatever benefit the new law may have


This leads me to believe that you can put in any number for Japan in your spreadsheet- big or small- and still its all quite reasonable since the opportunities are there in view of the law on conditional approval- just not the information. Those 9 or so trials Hedrick referred to back in 2013, have not gone up in smoke and each has unknown potential. :whistle:

Please Log in or Create an account to join the conversation.

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:

SME Status granted by EMA 25 Mar 2016 16:54 #6717

  • cytxer
  • cytxer's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 347
  • Thank you received: 25
***Those 9 or so trials Hedrick referred to back in 2013, have not gone up in smoke and each has unknown potential. ***


Three years of long term investors suffering and he is keeping it to himself while giving the company away? sounds like Marc alright...

:winky:

Please Log in or Create an account to join the conversation.

SME Status granted by EMA 25 Mar 2016 18:20 #6718

  • rothco619
  • rothco619's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 467
  • Thank you received: 67
Marc told me Cytx had hired new pr/ir firm. I'd like to see some news to improve image before rs. Get this lagger up above $1. Show some good will to your long term ,long suffering stuckholder's instead of wipeing us all out. Avoid the scrutiny a class action will bring to light on the mismanagement and appropriation of funds etc, that has occurred over the years since shares have dropped from $8.50 to .14.

Please Log in or Create an account to join the conversation.

  • Page:
  • 1
Time to create page: 1.064 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites