Replies to post #164722 on Biotech Values

[DewDiligence]

I don’t think VX-135 will ever get off the FDA clinical hold at 200mg; there’s just not enough margin for safety at that dose, as discussed in prior posts by jq1234 and me.

[oc631]

Obviously, there is still plenty of work to be done to prove the drug is safe and get it off the hold of the 200mg dose.

There was never any guarantee VRTX would advance the Simeprevir/VX-135 combo beyond Phase-2. Even if the results were spectacular. The U.S. clinical hold could work in JNJ/Medivir's favor if their in-house nucleotide program(s) have hit a dead-end.


Does BMY want to license or partner with another potentially unsafe nuke after INX-189? What if VX-135 is restricted to the 100mg dose in the U.S? JNJ could potentially license VX-135 ex-U.S. on more favorable terms (after the clinical hold) and advance the Simprevir/VX-135 combo using the 200mg. dose. This would make a fine follow-up to Simeprevir/PegRiba in secondary markets.



I was initially too harsh on the potential for VX-135 after the U.S. hold on the 200mg dose. If the drug can be test at 200mg in Europe there's certainly value barring another safety issue.