More, From Merck — On Vorapaxar Travails. . . .


This was from the official Thompson’s transcript of last week’s Barclays Miami conference (see last page of that PDF file):

. . . .Q.: Tony Butler | Barclays Capital | Analyst

Thanks very much. Just a question on Vorapaxar if I may. If you actually think about what you do know, is — because the [blind] must have been [broken] by the DSMB, the question becomes are statistics then therefore irrelevant for 2P? That’s number one. Number two, what would be the best outcome that you could arrive that based upon TRACER and 2P today? Would that be a subsequent new trial in non-stroke patients or something else?

A.: Luciano Rossetti | Merck & Co Inc | SVP of Global Scientific Strategy

Tony, it’s very, very difficult for me to speculate at this stage because truly what we know from the DSMB is so minimal. Remember the mission of the DSMB is the protection of the safety of the patients within the trial, that you can argue that this is obviously the mission for everyone involved. But there is a component of also an interest in finding out the answer, because that benefits the larger population.

But that is not the DSMB mission. The DSMB mission is to protect the safety of the patients within the trial. So overall what I can tell you is the DSMB has recommended that we continue dosing about 75% plus of the patients in TRA 2P. That will take a little
bit longer time but we really look forward to looking at that data.

We also look forward to look at the data of TRACER, because as I mentioned, we have achieved the number of events to make a scientific determination of the trial. And so we’re going to examine those data. We have no knowledge of what the data is going to tell us in terms of safety and efficacy or subgroup analysis. And only after that I can start to have a cogent debate with you about next steps. . . .

We’ll check in on this, from time to time.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s