This is new to me:
"Pharming and Santarus were recently informed by the FDA that an Advisory Committee is not likely to be required as part of the RUCONEST review" Sounds good!
"For HAE prophylaxis, we submitted, under our investigational new drug application, a protocol to the FDA with a request for a special protocol assessment, or SPA. The FDA has indicated that modifications to the protocol are needed before proceeding with the study and further discussions will be required in order for the protocol to be approved pursuant to the SPA process. We and Santarus are evaluating next steps to move the program Forward"
No advisory committee for a new investigational drug....incredibly positive sign!
Also, Ruconest showed a positive benefits for replacement therapy prior to kidney transplant. WOW, this company continues to impress