The article's corresponding author and a Principal Investigator in the MCNA
pivotal Phase 3 study, Dr.
The opportunity to obtain marketing authorization of MCNA
from regulatory agencies in geographic regions beyond the U.
The FDA's Prescription Drug User Fee Act (PDUFA) review goal date for MCNA
is February 27, 2016.
The FDA Advisory Committee meeting discussing Telesta's bladder cancer therapeutic, MCNA
, will be live webcast by the U.
Michael Berendt, Chief Executive Officer and Chief Scientist of Telesta Therapeutics noted: "Ipsen is the ideal commercial partner to bring MCNA
to patients in the key pharmaceutical markets outside of the United States.
Michael Berendt, Chief Executive Officer and Chief Scientist noted that "This advisory committee is another critical step on our path towards potential approval of MCNA
as the first new therapeutic for bladder cancer patients in decades.
speciality pharma company, anchored by MCNA
, our drug for high grade non-muscle invasive bladder cancer patients.
FDA for MCNA
on June 29, 2015 and expects to receive communication letters from the Agency in the next 30 days on i) the priority review determination (the Agency will grant either regular (10 month) or priority (6 month) review); ii) any filing issues identified; and iii) whether the Agency will establish an advisory committee as part of their review process.
TSX: TST) (PNK: BNHLF) announced today that it has received itsBLA Filing Notification for MCNA
from the U.
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.
Preparation of a Biologics License Application (BLA) for MCNA
, its therapy for the treatment of non-muscle invasive bladder cancer patients who have failed BCG therapy, is ongoing and remains on track for a submission by June 30, 2015.
Negotiations for the partnering of MCNA