Burning Off The “Fog Of Hype” | Around Merck’s FDA “Priority Review” Announcement, Yesterday


This post is to aid an anonymous commenter, below, and to recap and update post my November 23, 2010 piece on it.

What’s known: Vertex filed with the FDA on November 23, 2010. What’s also known: Vertex will update on FDA status by the end of January 2011.

What’s entirely unknown: which company actually filed first (and which will receive the first approval).

I strongly suspect Vertex did file first — but even if Merck was first, it would be unusual for FDA (in this new environment) to “keep all blinders on“, about each of the competing filings. There will almost certainly be discussions about relative efficacy, and relative regimen lengths, at FDA.

In that regard, even four weeks lead will be nearly nothing — in favor of Merck –if it occurs, at all. Assuming Merck gets an approval a few weeks before Vertex however, at least one stock analyst thinks it may well work to Vertex’s longer-term advantage — as it will give Vertex a chance to see Merck’s pricing strategy, and then price Telaprevir® to meet, or beat, it. See this squib of yesterday:

. . . .”We believe this gap in timing could benefit Vertex as it will gain visibility on Merck’s pricing of Boceprevir before announcing its own,” said JMP Securities analyst Liisa Bayko in a note to clients Thursday morning. “Moreover, the three-week lead time in the marketplace is unlikely to translate into much of a competitive advantage as we believe Telaprevir’s compound has a stronger profile with superior efficacy and a differentiated safety profile. . . .”

As ever, we shall see — but that last bit gets it just right.

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