Lemtrada fails to get US FDA Approval

[batman12]

The problem with the Lemtrada studies is that the manufacturer intentionally manipulated the data to make the effectiveness of Lemtrada look better than it really is. So there would be no way someone with MS could make a truly informed decision about what risks to take. That "as close a thing as there is to a 'cure'" impression was apparently built on a lie.

Just so that people reading this thread are clear - the above statement is untrue.

The FDA said nothing about intentional manipulation of the data - they didn't like the fact that there was no placebo arm.

Given that every other regulatory authority has approved the drug it looks like they are getting ready to change their mind too......

[Marco]

Given that every other regulatory authority has approved the drug it looks like they are getting ready to change their mind too......

Don't ever underestimate the stubborn nature of a government agency. It's going to be interesting to see how the data is presented differently this time around.

Do you believe the FDA will rule on Lemtrada this year?