boom $ qut, page-15

Hi TDA,

I have no interest in cross promoting another stock on this thread, hence why I avoided naming it, but I apologise to you and others if it appeared otherwise.

As a non-holder of TIS I have continued to express my support for this company on the TIS threads on a couple of occasions, and it still remains high on my watchlist, so was certainly no intention to upset anyone with my post.

I clearly never received the reaction I had anticipated, so apologies again.

Thanks for your reply in regards to my query re Prof Vowden, TDA and COLIN. I can accept what you are both saying is correct, however I still consider it somewhat strange that Tissue Therapies would go to the effort of citing an author in reference to a couple of very basic statements, who (without any TIS connection) is quite possibly developing competing technology, ...?

Hi Wisdom,

Haven't seen you for a while, hope you're are well mate.

I didn't intend for my post to be cryptic, nor to rub anyone up the wrong way, but on revision of the post, I can understand where I probably went wrong...

Putting it simply probably won't serve much purpose now as clearly no one shared my initial thoughts, however my post was in response to one from resourced in regards to the collaborations involved, and ownership of the Vitrogro ECM project. Clearly, Tissue Therapies, as the exclusive licensee is the major beneficiary of the technology - We all know that, however I've been searching for another project in the field of wound care management which disappeared into a confidentiality mode five years ago now after reporting and presenting some promising early stage findings from pre-clinical and human pilot studies.

Confidentiality agreements within the pharmaceutical industry are heavily protected contracts which make it extremely difficult for anyone conducting research to come to any difinitive conclusions, if that's the correct term, or connections for a better word.

What makes things a little more challenging for myself is that ALL current development programs involving the company I'm most heavily invested in, are protected by confidentiality agreements, and to add further challenges to the puzzle, they are also a "fee-for-service" provider in their field of expertise, which for example includes things such as permeation issues that a potential one-off or small client may need resolving in R&D programs.

I admit it may have been a little presumptuous of me when citing one of my company's collaborating scientists referenced on the TIS website and speculating a connection between two companies, however I hope some can still see what I mean when suggesting that the references citing Prof Vowden's name, are very basic and commonly referenced terms found in Wound Care Management...

Hard to heal wounds are defined as wounds that have not respond to standard therapy in an orderly and timely manner [1]. This type of delayed healing occurs in a variety of wound types (venous leg ulcers, arterial leg ulcers, mixed leg ulcers, diabetic foot ulcers and pressure ulcers) [1,2,3].

My question/comment in regards to PGT Healthcare derived in part from speculating a potential connection between the Prof and Tissue Therapies, and also in looking for a more plausible explanation to the ongoing CE Mark delays.

Now, I'm probably only going to get another serving from respected TIS posters in raising this, but it still forms part of an honest opinion, so here it is...

I'm struggling to believe that there have been any delays to the CE Marking, and in saying this I'm of the opinion that it has already been approved. I'm not pointing any fingers at management here - it has more to do with my own understanding and formed opinion of the Pharmaceutical industry as a whole.

Before being written off I also want to make something clear - I do believe that the CE approval notice will be announced to the market this month, I do believe TIS is currently under-valued, and I do believe management are working in the best interest of their s/holders, so I hope this post isn't seen as any form of down-ramp.

02 July 2012
“Assisting our application for the granting of CE Mark for VitroGro® ECM is the fact that we have rigorous data to show that it produces consistent healing with no adverse events....”???

“Regulatory approvals such as CE Mark are fundamentally based on the risk of releasing the new product for use by the targeted market. A low risk profile like that of VitroGro® ECM assists approval.”???

Rigorous data and low risk profile should assist approval -Absolutely, I couldn't agree more, and TIS would no doubt pass with flying colours, so what's the real issue...?

In July 2011 the market were advised, “I am very confident that we will have the data necessary for a successful submission for EU approval for sale, on time and as planned later this year when final manufacturing stability data is available."
In September 2011 the market were advised, The EU regulatory consultant is confident that the results already achieved are sufficient for EU approval for sale.
In November 2011, This audit found no non-conformances and the Company will shortly receive the certificates of compliance necessary for the sale of VitroGro® wound healing products in the EU and Canada." and then,
“We are confident that this data will be sufficient for EU approval for sale (CE Mark). The final piece we need for CE Mark is the validation data from our new, larger scale manufacturing process and this will be available during December 2011.” “We already have approval from an EU Notified Body, BSI, for an accelerated review which takes 45 days and so we have more than enough time for a second quarter 2012 sales launch in the EU.”

Is it not a little strange that TIS have continually expressed its confidence through these delays whilst other companies in Wound Care Management sector have been winning CE marking approvals way ahead of schedule...?

Hi COLIN,

"see this link.. show you post as a crock of sh.t"

I'm not sure if you're aware, but the quote you offered just before these friendly words was actually from another poster - not me. However, see this link.. my research blog on Tissue Therapies. I'd appreciate that if I've posted a crock of anything, you might be kind enough to offer some helpful suggestions ;)

"My initial investigations show that the PG and Teva JV called PGT Health care, is to utilise TEVA ability to convert current perscription drugs to over the counter products and leverage PG' over the counter sale network. I can find no infomation relating to Vitrogro or this type of development. It appears that Tissue therapies hold the world wide licences for Vitrogro."

I challenge you to find any information outside of Australia relating to TIS and its partner Quintiles, or TIS and partner, Movianto? As for TEVA's ability to convert current Rx drugs to OTC products and leverage PG's OTC sale network, I would argue if it would even be possible to find a better partnership for VitroGro, than the P&G/Teva duo...

Meet Polyheal and MediWound...

Teva investing $500 million in the wound care market
As part of the company's effort to expand into niche markets and to respond to mounting competition in the generic drug market as well as rivals to its first and most profitable original product, Copaxone, Teva Pharmaceutical Industries last week entered into nonbinding memoranda of understanding with Clal Biotechnology Industries subsidiaries MediWound (55% ) and Polyheal (41% ).

By going with Teva rather than one of the established leaders in the field, Clal Biotechnology, MediWound and Polyheal are betting on Teva's ability to get into the sector, with all that entails: creating sales and marketing networks for the main two wound-care markets, hospitals and burn treatment centers. Teva plans to develop a marketing and sales system to target the 60 chronic wound centers in Europe and the United States.
Teva - Polyheal

Poly Heal

"I think you need to look at your research you seem to be quoting unrelated development including stem cell technologies."

I can't recall ever making any reference to TIS and "stem cells, COLIN, however I have always assumed that the VitroGro technology could be translated into many other cell culture applications, even including the embryonic stem cell...

Anyway, I'm sure you are right, as research has never been my strong point...

By the way, Teva's double blind phase IV clinical trial of Polyheal-1 for patients suffering from venous chronic wounds, 73% met the trial's primary endpoint, which is not too bad compared to VitroGro's impressive data, however have you ever heard the words, chronic diabetic foot ulcers, cure and 100% clinical success rate used in the same sentence...;)

Toronto Medical Company Seeks $10 Billion Dollar Investment
Toronto, Canada (PRWEB) July 04, 2012
Saringer Life Science Technologies Inc. (SLST) is making headlines today as the Canadian manufacturer and distributor of medical devices is seeking an investment to fund a colossal business expansion plan. Launched in 2007, SLST has focused its efforts on two of its most advanced medical innovations to date; The Venowave VW5 and the ICE-O-therm. After years of clinical studies and product testing, both products use the latest state of the art technology (IP protected) and are ready to be commercialized. The products have a broad range of approved indications including pain treatment, preventing blood clotting or Deep Vein Thrombosis (DVT), and a broad range of vascular conditions including the most severe; Post Thrombotic Syndrome (PTS). Most recently scientists are studying the Venowave and its ability to heal chronic diabetic foot sores after an impressive case study was conducted with a 100% success rate. Many of these conditions are largely unmet clinical needs and alternative treatments are scarce. “We’re definitely on the verge of reaching one of our biggest milestones yet,” exclaims Saringer. Although the majority of investor dollars will go towards expansion and revenue generating initiatives, some will also go towards Saringer’s most recent focus: how the Venowave VW5- a sequential compression pump that attaches to the back of the calf in order to increase circulation - can heal diabetic foot ulcers. “It’s time to take things to the next level and find a cure for chronic diabetic foot ulcers.” - Toronto Medical Company Seeks $10 Billion Dollar Investment
Venowave - Wound Care Intervention