Liminal BioSciences Inc. PFSCF

RE:RE:DFU is on track for 2020 market approval... maybe earlier...

[DryBones]

Pure garbage speculation by BIO.  The idea that the FDA would alter their procedures to benefit PLI is bizarre.  We have already seen how they change their conditions to everyone's detriment.  

Biofinder wrote: With Ryplazim approval for plasminogen deficiency, the FDA may actually speed-up the trial requirements for DFU marketing since they both use the same ingredient, plasminogen, which of course is a naturally occurring human protein produced by the liver.

 

The DFU trial should be fairly quick lasting 6-8 months followed by the readouts. The phase II trial should be completed by Q2 2018, with readouts and FDA approval for a phase III trial to follow.

 

If the FDA requires a phase III DFU trial it should be completed by Q1 2019 and FDA marketing approval by H1 2020.

 

Since the FDA would have already approved Ryplazim (plasminogen), and if the DFU trial continues to see a 100% patient response rate like seen in the prior “compassionate use” cases, there is a chance that the FDA may waive the phase III trial requirement and allow market approval of plasminogen for DFU under conditional or limited terms, and that would move DFU to market in H1 2019.

Either way, DFU marketing approval by the FDA is ANOTHER GIVEN (it’s in the bag) to this investor since we’ve already seen a 100% success rate in the compassionate use patient cases, whether it happens in 2020 or 2019.

2019 to 2020 seems the years when everything comes together for Prometic for both the company and for investors as both the plasminogen and pbi-4050 franchises will be on the market by then.

2020 remains my target year for considering selling my Prometic stock, if we don’t get bought-out before then...

 

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