The ODAC Postmortem: Lessons Learned Part 2, Delcath Systems
Most Popular - In part 2 of the ODAC postmortem (see Part 1 on Aveo Oncology [AVEO] here), I will share my thoughts on the outcome of the … Continue Reading
Read nowAuthor Archives: Aafia Chaudhry, MD
The ODAC Postmortem: Lessons Learned Part 1, AVEO
Most Popular - Yesterday was a dark day for those holding Aveo Oncology (AVEO) or Delcath Systems (DCTH) through the FDA’s Oncologic Drugs Advisory Committee meeting. I was … Continue Reading
Read nowAveo’s Inflection Point: Tivozanib Likely To Receive Positive Advisory Vote, FDA Approval
Long Ideas - On May 2, 2013, AVEO Oncology (AVEO) is set to face the FDA’s Oncologic Drugs Advisory Committee (ODAC) for a review of the company’s New … Continue Reading
Read nowDelcath Systems: Bullish on Melblez FDA Panel Vote and Subsequent Approval
Long Ideas - Delcath Systems (DCTH) is developing Melblez Kit (melphalan) for injection use with the Delcath Hepatic Delivery System with a proposed indication for the treatment of … Continue Reading
Read nowSpecial Protocol Assessments: The Case Studies
Education - In my estimation, there have been approximately 114 PDUFA decisions relating to NDA/BLA and sNDA/sBLA’s in 2012. Of these, 97 applicants received drug approvals and … Continue Reading
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