Bladder Cancer PIII Results in 2Q 2010 !! Bioniche

Was meinst du Wolfsburg gegen Neapel?  

 

 

alles e....  

was überzeugt dich an der Bude so??  

 

http://finance.yahoo.com/news/...rovides-key-corporate-125000238.html  

der nächste Anlauf?
Hab letzte Woche nachgelegt  

.... so schauen wir einmal wie es Morgen weitergeht 

Letzte Woche ging es ja schon bissl hoch und hielt auch recht gut! 

 

 the United States Patent and Trademark Office has issued U.S. Patent No. 9,044,422, which provides intellectual property (IP) protection for Telesta's Mycobacterium phlei cell wall-nucleic acid complex (MCNA) composition of matter. 

Dr. Michael Berendt, CEO and Chief Scientist noted: "We are extremely pleased with the issuance of this U.S. composition of matter patent which provides strong IP coverage in the largest and most important commercial market for MCNA.

und wichtig noch einmal eine Aussage die darauf schließen lässt das der Termin eingehalten "wird": As previously reported, Telesta is targeting the filing of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for this therapeutic by the end of June.  

Quelle: http://www.newswire.ca/en/story/1548903/...mposition-of-matter-patent

​

 

Und jetzt wo News kommen sollten kommt nichts? Was ist los? BLA-Antrag?  

Montag ist auch noch ein Tag.
Schauen wir mal was kommt.  

Dienstag auch noch... aber warum alles auf den letzten Drücker? Dachte das Ding ist fertig und muss nur noch eingereicht werden?  

...ich auch....
Naja entweder die machen das k.a. warum auf den letzten.... oder sind wieder zu spät... oder bringen evtl.  ein paar news.

lassen wir uns überraschen.  

Na endlich:

   - BLA for MCNA submitted electronically to the US FDA on June 29th, 2015
   - Manufacturing facility upgrades completed and pre-launch production
     planning initiated
   - FDA waives US$2.3 million application fee for Telesta

Schön das die Gebühr entfällt.  

Quelle: http://www.prnewswire.com/news-releases/telesta-therapeutics…  

Die FDA verzichtet auf die Gebühren der BLA...

MONTREAL, June 30, 2015 /CNW Telbec/ - Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) announced today that it has submitted electronically, through its U.S. agent, a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for MCNA(1). MCNA is Telesta's novel biologic immunotherapeutic for the treatment of high-risk non-muscle invasive bladder cancer patients who have failed first-line BCG therapy.

Telesta also announced today that they have received from the FDA a waiver exempting Telesta from the payment of the $US2.3 million BLA application fee.

The FDA has a 60-day filing review period to determine whether Telesta's BLA submission for MCNA is complete and acceptable for filing, whether MCNA will be designated for priority review or standard review and whether an advisory committee meeting will be scheduled. Their decisions on these items will be communicated to Telesta in the FDA's official filing communication known as the "Day-74 letter". Telesta will communicate the FDA's filing decisions upon receipt.

Telesta's BLA submission has been made following extensive and ongoing dialogue with the US FDA, including a formal pre-BLA meeting in November, 2014 and a Type C facility meeting in February, 2015. As part of this process, Telesta has incorporated the FDA's recommendations into the current submission and the Company has also been working with top tier regulatory consultants to ensure that their BLA submission meets all current regulatory requirements.

Concurrently with this BLA submission, Telesta confirmed the completion of a number of upgrades and improvements to Telesta's manufacturing facility and operating procedures, undertaken following recommendations received from the FDA at the Type C facility meeting held in February. As previously announced, these improvements were implemented by Telesta to ensure that their manufacturing facility is well positioned for the FDA pre-approval inspection that will take place as part of the FDA's formal review process.

"The BLA submission for MCNA marks an major step towards our ultimate goal of providing bladder cancer patients and the medical professionals in the urology community, with a therapeutic alternative to radical cystectomy," said Dr. Michael Berendt, CEO & Chief Scientist of Telesta Therapeutics. "There is an urgent and unmet medical need to develop new therapies for bladder cancer patients who have not seen new therapies approved for almost 20 years. I am incredibly proud of Telesta's dedicated and talented employees, many of whom have been working for more than a decade to advance this important therapeutic agent, for their hard work and professionalism that has permitted us to achieve this key corporate milestone."

Current practice guidelines for the treatment of high-risk non-muscle invasive bladder cancer patients who are refractory to or have relapsed from first line BCG therapy call for radical cystectomy (surgical removal of the bladder and adjacent organs). MCNA was developed to provide a much-needed therapeutic option for these patients. This BLA submission is the first step towards the potential regulatory approval and commercialization of MCNA, which could become the first approved therapeutic alternative for these high-risk bladder cancer patients since 1998. The approval of MCNA in the U.S. could occur as early as Q1/2016 should the FDA designate the MCNA BLA submission for priority review.

Read more at http://www.stockhouse.com/companies/bullboard/...UHS1pIMhHuwMFLXl.99.  

Hier scheint Telesta auch noch sehr unbekannt zu sein wenn ich mir so den Thread anschaue.Das werden wohl einige noch bereuen ;-) mM  

Telesta Therapeutics Announces South Korean Partnership for MCNA & Concurrent Private Placement


MONTREAL, July 20, 2015

MONTREAL, July 20, 2015 /CNW Telbec/ - Telesta Therapeutics Inc. (TSX: TST; PNK: BNHLF) announced today that it has entered into an exclusive license, supply and distribution agreement with BL&H Co. Ltd., a leading Korean specialty pharmaceutical company, for the commercialisation of MCNA1 in South Korea.  Under the terms of this partnership, Telesta will receive a combination of upfront payments, regulatory milestones and sales milestones in excess of US$2 million in addition to a significant transfer price, allowing Telesta to receive a large proportion of the revenue related to MCNA sales in South Korea. Telesta will be responsible for the manufacturing and supply of the drug product, while BL&H will cover all costs for registration, sales and marketing in the territory. In addition, BL&H has concurrently subscribed for a private placement in Telesta common shares for an amount of US$200K at market price.

Dr. Michael Berendt, Chief Executive Officer and Chief Scientist commented: "We are pleased to have established this relationship with BL&H whose established track record of successful registrations, market access and launches of oncology and specialty products in South Korea were the deciding factors in our decision to choose to work with them for the launch of MCNA in this important market. This regional transaction represents our first transaction as we continue our discussions with potential strategic partners for all of the key global markets and as we move MCNA towards a near term regulatory approval in the United States, the world's largest pharmaceutical market."

Mr. D.C. Roh, President and CEO of BL&H noted that "MCNA represents a major breakthrough for the treatment of high-risk non-muscle invasive bladder cancer patients who have failed first line BCG therapy. In Korea, as in the rest of the world, this patient group and their treating urologists are very keen to have access to a therapeutic option, to prevent or delay radical cystectomy, a life-altering surgery. We are extremely pleased to have partnered with Telesta to be part of the global effort to bring forward this important medicine to patients."

The South Korean Food and Drug Administration registration process is adapted to products already approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA), Registration and price reimbursement can be expected approximately within one year from application. South Korea is currently the world's 14th largest market for global pharmaceutical sales.

About MCNA

Telesta submitted a Biologics License Application (BLA) to the U.S. FDA for MCNA on June 29, 2015. MCNA is a biologic therapy derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects. MCNA was developed to be delivered as a sterile suspension for intravesical administration by urologists and urology nurses, following the same dosing paradigm as first-line BCG therapy, with the advantage that it can be prepared, handled and disposed of easily and safely. The efficacy, duration of responses and safety data from MCNA's pivotal Phase 3 trial were recently published in the Journal of Urology2. Telesta continues to prosecute novel composition of matter, methods of use and manufacturing patents in most regions of the world and recently announced the granting of the key composition of matter patent in the United States providing intellectual property coverage of MCNA to 2031.

About Telesta Therapeutics Inc.

Telesta Therapeutics Inc. is a late stage therapeutics company with near term commercial potential focused on the manufacturing, marketing and licensing/acquisition of proprietary and innovative therapies for the global health market. The Company's primary goal is to develop and commercialize products that advance human health and increase shareholder value. For more information, please visit www.telestatherapeutics.com

About BL&H Co. Ltd.

BL&H Co. Ltd. is a privately owned pharmaceutical company based in South Korea. BL&H was established in 1999 with the aim of becoming a leader in the delivery of pharmaceuticals and services that fulfill unmet medical needs in the Korean market. BL&H specializes in specialty and hospital-based products in key areas including oncology. The BL&H management team has extensive experience in the pharmaceutical and healthcare sectors and in bringing specialty products to market.

Except for historical information, this news release may contain "forward-looking statements" and "forward-looking information" within the meaning of applicable securities laws that reflect the Company's current expectation regarding future events. Forward-looking statements and information are necessarily based upon a number of estimates and assumptions that, while, considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Readers are cautioned that any such forward-looking statements and information are not guarantees and there can be no assurance that such statements and information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements and information. These forward-looking statements and information involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. The Company expressly disclaims any intention or obligation to update or revise any forward-looking statements and information whether as a result of new information, future events or otherwise. All written and oral forward-looking statements and information attributable to us or persons acting on our behalf

___________________________________
1 Mycobacterium phlei cell wall-nucleic acid complex

2 Morales A, Herr H, Steinberg G, et al. Efficacy and safety of MCNA in patients with nonmuscle invasive bladder cancer at high risk for recurrence and progression after failed treatment with bacillus Calmette-Guérin. J Urol. 2015; 193: 1135-1143.  

Hallo zusammen, anscheinend ist das hier eingeschlafen....

Hier die News vom 19.08.15

Telesta Therapeutics Inc. gab heute den Abschluss einer Privatplatzierung über 28,6 Mio. USD bekannt!!!

http://www.finanznachrichten.de/nachrichten-2015-08/34711343-telesta-therapeutics-schliesst-privatplatzierung-ueber-28-6-mio-usd-ab-007.htm

Cash ist jetzt auf jedenfall gesichert!!!  Auch bei einer Aktienzahl von ca 280KK Aktien sehe ich ein hohes Potential da allein der US Markt ein Umsatzpotential von über 400KK $ bietet.

http://www.telestatherapeutics.com/cms/phpPUfSmq.pdf (Seite 24 Umsatzpotential US Markt )

Zudem steht ja die Tage noch die Entscheidung über die Einreichung des BLA Antrages aus.

Hier ein paar Insidertradesder letzten Tage:

Aug 20/15 Aug 18/15 Fortin, Lyne Indirect Ownership Common Shares 11 - Acquisition carried out privately 132,159 $0.341
Aug 20/15 Aug 18/15 Bastien, Yvon Direct Ownership Common Shares 11 - Acquisition carried out privately 117,474 $0.341
Aug 20/15 Aug 18/15 Fortin, Lyne Direct Ownership Common Shares 11 - Acquisition carried out privately 102,790 $0.341
Aug 20/15 Aug 18/15 Olds, Donald John Direct Ownership Common Shares 11 - Acquisition carried out privately 82,159 $0.341
Aug 20/15 Aug 18/15 Rae, James Moodie Direct Ownership Common Shares 11 - Acquisition carried out privately 50,000 $0.341
Aug 20/15 Aug 18/15 Berendt, Michael Joseph Direct Ownership Common Shares 11 - Acquisition carried out privately 190,602 $0.262

https://www.canadianinsider.com/company?menu_tickersearch=Telesta%20Therapeutics%20Inc.%20%7C%20TST

MfG

 

.... sich in Canada bis jetzt sehr gut  

http://de.advfn.com/borse/TSX/TST/chart

 

Ne Diskussion kannste hier vergessen - komm rüber zu W:O. ;)  

... bin ich schon vertreten. Ich wollte den Leuten hier (die nicht bei W:O sind) nur noch einmal die News und Aussichten darstellen bzw den Treath auffrischen. Klappt anscheinend nicht^^
Nicht das diese noch etwas verpassen ​

 

uns doch egal sein ;-)  

.........