Catalyst

Slingshot members are tracking this event:

Telesta Therapeutics Corporate Update - Type A Meeting with the FDA Scheduled

Do you think this event is important to the companies below? How will it affect their stock price?

Related Companies
Importance
High Medium Low
Impact on Stocks
TSX: TST; PNK: BNHLF Community voting in process
BJF.F Community voting in process
TST.TO Community voting in process

Additional Information

Additional Relevant Details  Type A meeting has been scheduled with the U.S. Food and Drug Administration (FDA) on Friday, April 15, 2016. This Type A meeting will be focused on the FDA's responses to Telesta's questions concerning the regulatory pathway forward for approval of MCNA1 in the United States. As previously announced, it is possible that the answers received to our first set of questions on the approval pathway and further clinical development of MCNA will require the preparation for and scheduling of a second meeting with the agency in order to be confident that the regulatory pathway in the U.S. is actionable for us or for a future partner for MCNA. In addition, we continue to collaborate with our key development partners to aggressively define and develop the regulatory approval pathway in their respective jurisdictions. Telesta will provide a corporate update following an analysis of the Type A meeting’s outcome and distribute this update via a press release on Monday, April 18, 2016
http://www.telestath...
Slingshot Insights Explained
Catalyst Date
Occurred on:
Apr 18, 2016
Occurred Source:
Related Projects Image
  • Don’t see a project related to the catalyst you care about?

Related Keywords Mcna1, Type A Meeting, Non-muscle Invasive Bladder Cancer, Bacillus Calmette-guérin