Trilogy International Partners Inc T.TRL.WT.A

RE:RE:Re: Canadian Business Article on Tefina

[LTOWNER]

Pharma, Rossi was not preparing us for rejection of Compleo.  He was directly responding to the authors’ suggestion that “the fate of Tefina could also depend on what happens with Trimel's lead product”.  I am glad it came up and that Rossi is ‘insisting’ Tefina development is not contingent on Compleo.  This suggests funding for Tefina development will be independent of funds diverted to Compleo.  The fact that “it will be a lot clearer once the Phase 2 study is completed” suggests once more there are negotiations going on behind the scenes of which we are unaware, involving not only a Compleo partnership but a Tefina partnership as well.  Whether or not the two will be linked remains to be seen.  Whatever is happening may also explain the recent willingness of Dr. Bryson to leave Cynapsus Therapeutics to join Trimel before Compleo hears from the FDA and before Tefina results are reported.  The first Tefina P2 results were very promising and this management team has great confidence in the results of the second P2 trial.  Hope they are proven correct.
 
The author made an effort to provide a balanced piece but it is not a very in-depth article and only skims the surface.  The fact that the author believes Tefina is a nasal spray and even pictures a model closing one nostril and sniffing in is unfortunate.  The deposit of testosterone gel in the ‘sweet spot’ of the nasal mucosa is key to its rapid absorption/rapid action, low dose, ‘as needed’ application and speedy exit from the blood stream - all information which differentiates Tefina from previously failed products like Libigel.   The author also failed to check recent press releases before publishing or he would have known the FDA decision is no longer expected in February!
 
All that being said, approval of Compleo is not guaranteed – until the fat lady sings!  I feel better about the 3 month delay after reading lousaboy’s account of IGX.  IGX filed an amendment but was still rejected on its PDUFA date without the FDA even reviewing the amendment.  In addition Trimel followed a suggestion by the FDA itself to seek TID-only application, which should strengthen the probability of approval.