As we await the FOIA and Congressional Inquiries response, a concern regarding Actinium Pharmaceuticals management was brought to light.
https://www.actiniumpharma.com/about/management-team
Three 3 key individuals were removed from the Management Team Web Site who would be needed in the BLA process.
Sunitha Lakshminarayanan
CMC & Product Development Leader
• Establish and oversee the implementation of the overall CMC strategy for BLA submission, preclinical, clinical, and commercial programs
• Manage and oversee all CMC activities related to radiotherapeutics, including budget and projections
• Create CMC project plans and timelines to meet key corporate goals on time
• Lead outsourcing of mAb and Drug Product manufacturing activities and contract negotiations
• Oversee external manufacturing operations, MSAT, CMC Regulatory, quality assurance, quality control, process and analytical development, supply chain, and project management functions
Lynn Bodarky
Chief Business Officer
William van der Touw
Senior Vice President, Research & Development
As it appears, Sunitha's perceived departure from Actinium would make it difficult to continue to submit a BLA in the USA for Iomab-B. William was originally going to present Iomab-B at the 3rd Targeted Radiopharmaceuticals Convention in San Diego in early August, however, at least minute was replaced by Monideepa Roy.
We have ~1 week at the earliest before we can expect to see a response from the FOIA and inquiries sent to the FDA.