Merck Still Testing

[Magnum]

Just spoke to my contact at Merck today. They are still in Clinical Trials Phase III with Beceprevir but nearing the end. He mentioned the FDA does not allow for them to give out any advanced notice as to applications, Anemia results, trail results, etc... Seems odd to me, but there it is.

I specifically asked two questions: The anticipated Fast Track application date and the Anemia question. Sorry to say that although he was very patient and understanding of my concerns on these two points, he couldn’t give me a direct answer to either question. So on we go with the waiting game once more...

Magnum

[Willy50]

Thanks for the update.  Last I had heard Boceprevir had started a rolling application.  Vertex had done the same by mid November but by the first of the month Vertex had their NDA filed.

I'm sure it will be headline news when Merck files for a Boceprevir NDA.  It will still be open to opinion how fast either gets approved.

Vertex seems to be first to file, w/ better efficacy.

Boceprevirs also allowed the use of rescue drugs to the best of my knowledge, whereas Vertex did not.  Whether that will effect approval speed is unknown, but it could play in.

FWIW, Vertex is still mum on pricing.  I'd venture they will remain so until approval.

Willy

[copyman]

this will give Telaprevir a big jump on the market for sure. I have a feeling there is more to the anemia problems otherwise they would have filed with FDA to get Boceprevir to market around the same time as Telaprevir.

When a competing drug beats another to market it is a big deal. The drug that comes out first has a big advantage to lock doctors into prescribing "only" their drug. Plus the success rate will give doctors the confidence to write that drug for patients.

oh well only time will tell

[HectorSF]

Thanks for the update!

hectorsf

[smaug48]

Thanks for continuing to push them, Mag, I think it helps