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Lemtrada Petitions

|Includes:Sanofi-aventis (Value Right) (GCVRZ), SNY

If you are interested in signing a petition in favor of approving Lemtrada as a new MS therapy, there are several ongoing petitions. For your convenience, here are links to each.

Thousands of Multiple Sclerosis patients are getting worse each day; They need another Option, another choice

Posted by Stu's Views and MS News

There are currently 788 petitioners in support of Lemtrada. S. Mitchell Freedman, MD, FAAN, signed the petition and added that,

I am a neurologist who has practiced for 35 years. Lemtrada is not for every patient but there is a substantial number of patients for whom it would be an appropriate treatment.

Lemtrada for FDA Approval for Treatment of Multiple Sclerosis

Posted by Lisa Dasis

There are currently 327 petitioners in support of Lemtrada. One petitioner, Dr. Sheldon Robbins, said,

Despite the fact that the FDA staff reviewers presented a series of questions that were structured to elicit a negative vote on adequacy of trial design and the efficacy of Lemtrada over Rebif, the panel members of the Advisory Committee voted overwhelmingly that the sponsor, Genzyme, provided adequate evidence of effectiveness. The panel voted unanimously that, assuming efficacy results are as they appear, safety concerns should not preclude approval.

The FDA should convene a new advisory panel composed of MS experts who have the perspective and judgment to render the appropriate advice for approval of this transformative medication. US patients deserve the right to choose the appropriate MS therapy in conjunction with their physicians.

I recently published a guest blog post on Lisa's site.

Melissa Burdick - Citizen Petition

Posted by Melissa Burdick

You can comment directly to the FDA via this citizen petition. There are currently 16 comments in support of Lemtrada.

Disclosure: I am long GCVRZ.

Additional disclosure: Chris DeMuth Jr is a portfolio manager at Rangeley Capital, a partnership that invests with a margin of safety by buying securities at deep discounts to their intrinsic value and unlocking that value through corporate events. In order to maximize total returns for our partners, we reserve the right to make investment decisions regarding any security without further notification except where such notification is required by law.

Stocks: GCVRZ, SNY