KMDA

[holdencf]

Why do ARWR shareholders give a damn about Kamada?  Because KMDA's ATT drug, which reached its primary endpoint, received ODD and was first into the clinic.  ARC-AAT also received ODD which means its therapeutic was either more efficacious, safer or both at the time of application. So KMDAs PR is a definitional confirmation that ARWR has a best in class drug.  Conversely, ALNY has not received ODD over a year after dosing while ARWR received ODD 30 days after dosing.  

[buffettlike]

The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In fulfilling that task, OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. Orphan drug designation provides incentives for sponsors to develop products for rare diseases. These incentives include increased engagement with FDA on drug development activities, exemption from all future product-specific regulatory fees, the opportunity to apply for R&D funding, tax credits, an increased chance of priority review, and 7 years of orphan exclusivity at time of New Drug Application (NDA) approval. Arrowhead Press Release~June 10, 2015