Trilogy International Partners Inc T.TRL.WT.A

Simply incompetence.

[MelnykWasRight]

For the conspiracy theorists, keep your friends close and your enemies even closer.
 
I’m a pharma company submitting an NDA to Health Canada.  I should know full well that Health Canada has adopted the International Council for Harmonization (ICH) technical guidance.  I would be expected to understand this ICH guidance inside and out before submitting my NDA, ensuring that the information submitted in the NDA meets the ICH technical guidance standards.  I should also understand that “the provision of additional quality information related to the” NDA may be required as a result.  I should be prepared to submit that information immediately if requested to do so (I’m assuming it wasn’t an actual requirement of the application process initially).
 
It is self-evident that the NDA in this case was submitted without a complete understanding of the ICH guidance process and requirements.  Otherwise, they would already have this information available and it wouldn’t be necessary to “to assess the pathway required to address the deficiency noted by Health Canada”.
 
These NDA mistakes have not been minor clerical errors.  I’m chalking this one up to continued incompetence on the part of management.  They punted the people that really understood the business and Health Canada processes.  As long as no one is held accountable for their missteps, this will continue to be a long, slow and painful death.
 
Pathetic is the only way left to describe the situation at this juncture.
 
MWR