RE:A Rational Thought...Over reaction? Here's the comment from Canaccord:
The news is more significant than people may think.
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Investment Highlights
• FDA provides validation for ‘4050 in IPF. We had viewed the pre-clinical data for
PBI-4050 to be very supportive of its applicability in IPF. However, we believe that the
FDA’s buy-in for a pivotal clinical program in IPF provides tremendous validation in this
indication, which may prove to be the largest blockbuster opportunity for PBI-4050.
• Visibility of an abbreviated path forward. The ‘green light’ to file the IND with the FDA
in IPF provides a clear path forward with the potential to reduce development timelines
substantially. This could allow investors to see Phase III clinical evidence in IPF much
sooner than expected and also reduces regulatory risk, in our view.
• Potentially a more attractive asset to big pharma. The FDA has agreed to allow
ProMetic to evaluate PBI-4050 as add-on therapy to the existing standard of care
(either pirfenidone (Esbriet) or nintedanib (Ofev)). Based on the observed synergistic
effect of ‘4050 in combination with pirfenidone in preclinical studies, we believe that
this could significantly reduce clinical risk. Armed with the FDA’s blessing, lower clinical
and regulatory risk, as well as a shortened development timeline, ‘4050 could now be
an even more attractive asset for big pharma.