Liminal BioSciences Inc. PFSCF

re NEWS

[barcodewhiz]

The big takeaway for me is the removal of the FDA's original criteria including patients on Pirfenidone.  This reduces trial size and cost.  Makes sense to go with the one that clearly works better in combination. 

And perhaps  more importantly, the opportunity to include a single trial design to prove efficacy in the non tolerance arm.  Pierre had said that as much as 20% of the IPF population wont tolerate either of the current standards of care, which is in itself a very significant opportunity.  In a nutshell, to me this makes 4050 that much more attractive to a prospective licensing partner.  Its basically a second shot on goal as well.

Because of the apparent drug interaction between 4050 and Pirefenidone, whereby patient FVC decline was similar to placebo in the large randomized trial, the further readthru is that we effectively already have a small comp against placebo  for nintedinab /4050 combo

I suspect this will be seen very positively in the industry and should heighten deal tensions if my read is correct

Most (if not all) of the patients in the PLI combo trial were already on one of the existings standards of care... Pirfenidone or Nintedinab.

no revenue... but this ups the ANTE meaningfully... and also serves as further validation of the 4050 efficacy data which some tried so hard to discredit.... and the need for placebo....  well we just found out we already effectively have  a measure against Placebo from this trial based on the 4050 / Pirfenidone combo resuts.   Fascinating development