Telesta Therapeutics (TSX:TST) - 500 Beiträge pro Seite

[Roboterotze]

Telesta Therapeutics Announces Key Clinical & Corporate Updates

MONTREAL, Dec. 1, 2014 /CNW/ - Telesta Therapeutics Inc. (TSX: TST; PNK: BNHLF) (Formerly Bioniche Life Sciences Inc. TST:BNC) today affirmed that they remain on track with their internal objective of filing a Biologics License Application (BLA) for marketing approval with the US Food and Drug Administration (FDA) for MCNA 1 prior to March 31, 2015. Two recent key accomplishments include the completion of both a pre-BLA meeting with the US FDA and a mock-audit of Telesta's MCNA manufacturing facility. As the result of the pre-BLA meeting, Telesta received written answers and verbal feedback to a number of clinical, manufacturing and regulatory items related to the filing of their BLA while the manufacturing "mock-audit" saw a third party firm complete a detailed and exhaustive review intended to simulate the type of audit that Telesta is expected to be subject to, by the FDA, during the course of a BLA review process.

Commenting on these achievements, Dr. Michael Berendt, Chief Executive Officer and Chief Scientist noted that: "We will continue to challenge ourselves and our expert consultants to ensure that the BLA that we ultimately file, will be the best BLA that we can produce. At this critical juncture in our history, nothing is more important than achieving our ultimate goal of delivering to non-muscle invasive bladder cancer patients who have failed first line BCG therapy, a new and efficacious therapeutic option."

In parallel, Telesta expects to conclude their third party assessment of the market opportunity for MCNA, in the United States, in the weeks to come. This market assessment, where qualitative and quantitative primary market research was conducted with payers (managed care organizations/decision makers both from the private and public sector) and urologists (community urologists and key opinion leaders), will address issues such as market size, pricing/pricing strategy and market access context/reimbursement potential for MCNA. These data will be key in assisting Telesta to make informed decisions concerning overall market potential and optimal licensing/partnering and/or commercial development strategy.

Telesta also announced today that its Board of Directors has accepted the resignation of Mr Greg Gubitz as a Director of the Company. Mr. James Rae, Chairman of the Board of Directors stated, "While Greg was a positive and thoughtful voice at the Board and Board committee levels, the Board must acknowledge the voting results of the November 12th, AGM. We will be conducting a search for a new Director in the weeks to come.

From today, going forward, Telesta Therapeutics will trade on the Toronto Stock Exchange (TSX) under the new ticker "TST" (TSX:TST). Telesta Therapeutics will also be announcing the launch of its new website in the weeks to come.

[Rainolaus]

sehr interessanter Wert ;-)
könnte ein Tenbagger werden :-)

[Reconstructor]

Antwort auf Beitrag Nr.: 48.471.983 von Roboterotze am 02.12.14 12:49:52

Klingt vielversprechend

[Roboterotze]

Antwort auf Beitrag Nr.: 48.482.258 von Rainolaus am 03.12.14 18:38:03

....und vor allem wie aus dem Nichts erschienen

Aber mal Spass beiseite....
Als nächsten Kurstreiber sehe ich die Veröffentlichung des Markt- bzw. Umsatzpotentials in den "kommenden Wochen". Bis dahin wird sie wohl weiter bei 0,21-0,23 CAD verweilen...

[knarre91]

Ja dann mal auf eine grüne Zeit =)

[illmatix]

moinsen,


jetzt findet es auch die suche

der bericht sollte noch vor weihnachten kommen

[Gansruhig]

Damit man`s schnell mal eben findet, auf Seite 1.



TMX Money Telesta

http://web.tmxmoney.com/quote.php?qm_symbol=TST

Kurs Deutschland

http://www.onvista.de/aktien/handelsplaetze/TELESTA-THERAPEU…

http://www.tradegate.de/orderbuch.php?isin=CA87953B1094

[allin123]

der alte Fred wurde nun mit TST verknüpft, bitte da weiterschreiben

[DALIDA]

!

Dieser Beitrag wurde von CloudMOD moderiert. Grund: Auszug aus Individualkommunikation, nicht verifizierbare Inhalte, private Mails gehören nicht ins Forum

[Roboterotze]

Antwort auf Beitrag Nr.: 48.486.260 von allin123 am 04.12.14 10:55:24

Oki doki - ich schreib mal dem MOD, dass er diesen hier schließt..

[CloudMOD [Mod]]

Hallo liebe User,

auf Wunsch des Threaderöffners schliessen wir diesen Thread.
Eine aktuelle Diskussion findet ihr unter
Thread: Diskussion zu Telesta Therapeutics -- ehem Bioniche Life
Vielen Dank !

Freundliche Grüße CloudMOD