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MyTomorrows

14 Jun 2017 08:13 #9462 by franshei
New life for the MAP program, with expansion into Middle East and Latin America.

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14 Jun 2017 09:44 #9463 by fas

franshei wrote: New life for the MAP program, with expansion into Middle East and Latin America.


Now that is an interesting thought, Franshei.

What gave you the "inspiration" for such an unlikely scenario, in view of past events? I mean, not pursuing the MAP was a pricing issue for charitable organizations- you think that pricing issue is solvable?

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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14 Jun 2017 09:47 #9464 by fas
Oops- now I saw the announcement

Partnership to Launch at the EULAR (European League Against Rheumatism) Congress in Madrid, Spain June 14-17
SAN DIEGO, June 14, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) ("Cytori" or the "Company"), announces its new managed access program partnership with myTomorrows at the European League Against Rheumatism (EULAR) Congress in Madrid, Spain between June 14 and 17. Cytori and myTomorrows share the goal of providing early and ethical access to Cytori’s Habeo Cell Therapy™ to patients in Europe, Middle East and Latin America.
“Providing compliant access to patients who may benefit from therapies in clinical development is the objective of Managed Access Programs (MAP). Habeo Cell Therapy fits the defined parameters of a MAP-eligible therapy. Towards that end, Cytori is excited to leverage myTomorrow’s expertise and expanded scope to take our MAP in a new direction,” said John Harris, Vice President and General Manager at Cytori. “We look forward to kicking off our relationship at the EULAR congress in Madrid, Spain this week.”
myTomorrows is an innovative and fully integrated organization dedicated to providing fully compliant early access to innovative therapeutics in advance of the products full marketing authorization in the countries that it serves. myTomorrows will serve as Cytori’s exclusive MAP for patients with scleroderma-associated hand dysfunction. myTomorrows will leverage its footprint to provide patients early access to Habeo Cell Therapy for the Middle East and Latin America in addition to Europe.
“The opportunity to collaborate with Cytori to lend support to patients in need is exactly in line with our team’s mission and core competences,” said Govert Schouten, Co-Founder and Chief Business Officer at myTomorrows.
The EULAR Congress is considered to be a major event in the global rheumatology network and seeks to serve as a platform to facilitate interactions between patients, medical doctors, scientists, health professionals and industry surrounding scientific and clinical information. Cytori Therapeutics’ booth is #47 in the main congress hall, where we will highlight the STAR and SCLERADEC-II clinical trials that are currently in progress in the U.S. and France, respectively. Representatives will be available to answer questions about the Habeo Cell Therapy Managed Access Program.
myTomorrows will be responsible for the design, implementation, and performance of the Managed Access Program and their Netherlands-headquartered and field-based teams will apply their knowledge and expertise toward physician and patient support, legal and regulatory administration, pharmacovigilance, logistics, and data collection.


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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14 Jun 2017 09:54 #9465 by fas
Question remains why MyTomorrows partner arrangement has no difficulty with the pre-determined price point post approval and apparently IDIS did.

Typical Cytori to simply ignore that issue.

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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14 Jun 2017 11:23 - 14 Jun 2017 11:24 #9466 by DOV
Here are a couple of bullets points:

IDIS' agreement did not provide much incentive for them to market Habeo in the MAP program. I forgot the amount they received per patient, but at one time I knew that number and probably posted it here. The financial arrangements between Cytori and myTommorrows are much more aligned, however, the details are not yet ready to disclose.

MyTomorrows' agreement extends beyond EU approval, where the IDIS agreement extended up until approval was reached in each country

This agreement is for a MAP arrangement and does not preclude Cytori from making a deal with an EU Pharma or specialty Pharma that would include upfront cash and a full marketing agreement.

MyTomorrows is a much more sales oriented company versus IDIS being very good at navigating the regulations. That remains to be seen.

No idea about any changes in pricing, but I do feel the revenue split is a much more motivating factor. Star data will help get this MAP moving where IDIS had only Scleredec1 to use for marketing
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14 Jun 2017 12:59 - 14 Jun 2017 13:11 #9467 by fas
Thanks DOV.

That implies a lot of flexibility and since they are a Dutch Company and history has proven that the Dutch can sell anything and are only second in that respect to the Chinese, I do have sympathy for the arrangement. The information you provide, is very important and I believe should have been part of the announcement or shareholder note, whatever it was.

I still believe, their information sharing is poor and incomplete.

Anyway- yes- I do recall you mentioned 1000 $ several times as IDIS´s part of the cake and also you questioned at numerous occasions the limited incentive for IDIS to provide the therapy to patients in the 9 countries that approved the MAP program.

This IDIS thing has been a tremendous waste of time and effort it seems and has cost the shareholder dearly- instead of revenues of 10-25 Mio in 2017, we received a secondary at 1,10 (and 30% dilution) after paying as shareholder 2,55 the year before.:evil: :bang: :bash: ...than again - the new deal will surely qualify for some big bonuses for the gang.

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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14 Jun 2017 13:27 - 14 Jun 2017 15:32 #9468 by franshei
DOV Agree

IDIS is very much like a CRO, trying to sell experimental therapeutics for organization such as Memorial Sloan Kettering. Many years, there was an NCI big shot trying to do the same out of Franklin, Tenn - it failed.

The IDIS sclerodemra charge per patient is over $ 50,000 (I think it was $ 65,000 - you had complained that it was too high) which may make patient recruitment difficult, particularly when the French phase 3 trials (4-5 sites) are still ongoing (people may be treated for free there).

Before US FDA approval, American patients may go to a Latin American treatment center.

Afterthoughts: Yahoo Reader (the old Chuck) and others. On May 51, 2017, there is a gap around 1.01 to 1.03. Today's drop may have filled this gap (Hedge is not here to comment on this). The recent PPS rise has created 2 gaps: one at 1.01 to 1.03 and one at 1.05. Let us hope the recent drop has completed the trading cycle - someone may have made money again!

I suspect someone has made a lot of money over the years trading CYTX, based on some very simple rule: sell on spikes or sell on news and wait out on filling the gaps. You do not really need to watch the trading tape all the time (waste of time).

To break this cycle, I believe CYTX needs new investors (pharma and biotech types who are not counting on current revenues, because r/d and its potential counts more) and new analysts (pharma and real biotech types who would think the same way). I think if we are counting the beans with all kinds of spreadsheets is not meaningful at this time, because for a typical biopharm, the future is more important than it is now, when there is enough financial backing and it is not falling over the cliff. I think the problem is that Hedrick has not spent enough time to explain the company's new road map, after the restructuring. Tiago Girao does not have the skill to do the same. The road map has always been murky and most current investors are making guesses all the time.

I have told Tiago Girao many times that they need professional help to manage the PR. They have tried to save money and Taigo Girao to handle this PR. As a foreigner myself, I would say Tiago Girao is doing a good job, but not good enough. When you listen to him during the conference calls, I do not hear a very articular messager.

Mr. Yahoo Reader, I know you talk to Tiago all the time (so is DOV). Please tell them what many investors are thinking. I am not the type to talk to him!
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15 Jun 2017 12:32 #9469 by fas

franshei wrote:
I believe CYTX needs new investors (pharma and biotech types who are not counting on current revenues, because r/d and its potential counts more) and new analysts (pharma and real biotech types who would think the same way). I think if we are counting the beans with all kinds of spreadsheets is not meaningful at this time, because for a typical biopharm, the future is more important than it is now, when there is enough financial backing and it is not falling over the cliff. I think the problem is that Hedrick has not spent enough time to explain the company's new road map, after the restructuring. Tiago Girao does not have the skill to do the same. The road map has always been murky and most current investors are making guesses all the time.


Sure, sure Franshei- CYTX needs new investors, preferably large institutions who like a big piece of the joint. But mind you, the present analysts and us too are all looking at spreadsheets since Cytori DECLARED THEMSELVES as a COMMERCIAL COMPANY in 2008 already and NOT a BIOPHARMA DEVELOPMENT outfit any longer. A home made blunder- Calhoun/Hedrick style.
At the time they received CE mark In Europe for Celution with very limited claims. They established Mentor distributors in Europe since a deal was pending with them in those days, but it never came off. So, off Hedrick went to Europe to live like a king in Florenz and convert KOL´s (Key Opinion Leaders). Of course that did not work, simply because of the facts in this slide-

The pharma and biopharma business is NOT DEVELOPMENT dominated but MARKETING dominated and even more so for unknown-, new technologies. The private pay market was a disaster withour marketing resources and the money available was wasted on the Big homerun apps in Cardiac and suiing the FDA.
Thats why folks are still looking at spreadsheets, although I agree - they never should have- since without FDA approved reimbursed products and no marketing resources , you do not get very far.
I believe that will all change- if CYTX is partnerable, like I think they are, we will become a real big Company some day. If not- the niche apps in the US and Japan will also do for a mid-size outfit.

By the way- the image is from an article by the Washington Post- link HERE

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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