TG Therapeutics Inc (TGTX)

[Ecomike]

Reminder of recent news:

NEW YORK, July 21, 2011 (GLOBE NEWSWIRE) -- Manhattan Pharmaceuticals, Inc. announced that the Company has reached an agreement with the U.S. Food and Drug Administration (FDA) on a special protocol assessment (SPA) for the design of a Phase 3 clinical trial of AST-726 in patients with a confirmed medical history of vitamin B12 deficiency. Manhattan has designed an open label, multicenter study for investigating the maintenance of trough serum cobalamin levels after monthly administration of AST-726, with a goal of enrolling approximately 75 subjects and a goal of having 53 evaluable subjects complete the study.

An SPA is a written agreement with the FDA that the study design and planned analysis of the sponsor's Phase 3 clinical trial adequately addresses the objectives necessary to support a regulatory submission.

AST-726 is an intranasal spray formulated as an isotonic aqueous solution of hydroxocobalamin acetate with preservatives.

I was told that this is a 100 million dollar per year market for AST-726!