Jt re the poster Poorgrad .
I was just looking for an informed opposing view......one of the reasons I thought poster Pyrrr was worth reading on the AMRN board ( eventually I found him relying on small old studies to support his views , so in the end didn't place much value on them )
Poorgrad had an informed ( read the background ) view on the earlier PRTO trials and correctly predicted that they would fail to meet their primary endpt.
However I don't think he is aware of the data on the secondary and tertiary endpts and how these end pts are now the new primary co endpts in this final trial ( Patency 2 )
From their Jan 24th 2019 PR
"
Based on the results of PATENCY-1, and following discussions with the FDA, Proteon amended the protocol for the PATENCY-2 trial, reordering the endpoints and establishing fistula use for hemodialysis and secondary patency as co-primary endpoints.
If PATENCY-2 is successful in showing statistical significance (p≤0.05) for both of the co-primary endpoints, Proteon expects to file a Biologics License Application (BLA) with the FDA in the second half of 2019 and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the first half of 2020."
So I was interested if this new information would change his mind re potential success of this final trial .
Haven't heard back from him .
May float it past Dew ,on his board "Biotech Values "
Anyway . I agree with you . I think they have a good chance of seeing a P value of <.05 in both endpts with the larger number in the trial ...altho the risk reduction for both endpts may be less then the previous trial.
JMO
Kiwi
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