FDA Freedom of Information Act (FOIA) Appeals Response Update - November 8, 2024.
"There are currently 69 appeals pending ahead of yours. Since appeals are processed on a first-in, first-out basis, I am currently estimating it will take 12 - 15 months to complete processing on your appeal."
Context: A Freedom of Information Act (FOIA) appeal was submitted in response to FDA FOIA response that could neither confirm or deny if Actinium Pharmaceuticals submitted a BLA to the FDA. Based on some people's interactions with Actinium Pharmaceuticals, the BLA was a precursor to the Expanded Access program for Iomab-B.
Assessment: Based upon the FOIA and appeal response from the FDA and Actinium's press release that the Phase 3 SIERRA trial is not adequate to support a BLA filing, it is believed the FDA issued Actinium Pharmaceuticals a refuse-to-file (RTF) letter for the BLA that identified deficiencies in the Overall Survival Secondary Endpoint. This belief is supported by the publication of the Iomab-B trial results in ASCO that demonstrated the control arm survival data was confounded by those that crossed over to Iomab-B. https://ascopubs.org/doi/10.1200/JCO.23.02018
Dr. Sergio Giralt, Deputy Division Head, Division of Hematological Malignancies and Attending Physician, Adult BMT Service at the Memorial Sloan Kettering Cancer Center, and leading SIERRA Trial investigator and corresponding author. My fellow investigators and I are disappointed that the SIERRA trial will not support the approval of Iomab-B despite the positive results and significant unmet medical need of this patient population. However, there is continued significant interest from the transplant community to participate in the upcoming phase 3 study with Iomab-B to provide patients access to this important drug candidate."
With a new trial, eligible patients would be able to enroll and gain an opportunity to access Iomab-B.
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Annual Meeting Notification
For investors with Actinium Pharmaceuticals.
The proxy statement and the 2023 Annual Report are also available at https://web.viewproxy.com/actiniumpharma/2024
You are cordially invited to attend the Annual Meeting of Stockholders (the “Annual Meeting”) of Actinium Pharmaceuticals, Inc. to be held at 9:30 a.m., Eastern Time, on November 27, 2024, at The Garden City Hotel, 45 Seventh St, Garden City, NY 11530.
You are required to register in advance of the Annual Meeting if you plan to attend the Annual Meeting in person. If you wish to register in advance of the Annual Meeting, please contact our investor relations office by no later than November 20, 2024, by e-mail to investorrelations@actiniumpharma.com, mail to Actinium Pharmaceuticals, Inc., 100 Park Avenue, 23rd Floor, New York, New York 10017, or telephone at (646) 677-3875.
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Annual Meeting Questions:
1) Can you clarify the August Phase 3 SIERRA trial is not adequate to support a BLA filing? When did Actinium Pharmaceuticals file a BLA for Iomab-B? Did Actinium Pharmaceuticals receive a Refusal-to-File and/or Complete Response Letter from the FDA?
Context: Actinium Press release on August 5th not-adequate statement.
2) What were the results of further discussions with the FDA? What will the new trial design look like and who is advising on the design? How long is it projected to take?
Context: Actinium to request a meeting with the FDA to further discuss specifics of additional trial
3) Why did Lynn Bodarky, Sunitha Lakshminarayanan, and Patrik Brodin leave Actinium Pharmaceuticals following the FDA response on August 5, 2024 and how does this affect commercialization of Actiniums drug and radio assets?
Context: Actinium managment web site doesn't indicate they are employeed. Linkedin announced a Head of Radiation Science position for cylotron tech.
4) With Actinium seeking a strategic partner for Iomab-B in the US and Immedica now expanded to the USA, will there be changes in the $452 million agreement between Actinium and Immedica?
Context: Actinium will seek strategic partner for Iomab-B in the U.S. following completion of FDA interactions and focus development efforts on Actimab-A, Iomab-ACT and preclinical programs.
5) Why Actinium Pharmaceuticals mislead patients, doctors, and investors regarding the potential outcome of Iomab-B and not discuss with the FDA sooner about conducting a secondary Phase III trial on Overall Survival?
Context:
In a November 1, 2022 interview with BenzingaTV, Sandesh Seth stated the following to current and future investors:
"FDA so they helped us with the trial design they, you know, mandated this trial of design."
"They [FDA] picked the primary endpoint so we don't expect any regulatory surprises."
"we don't have any competitors and look we have phase three data from a well-controlled trial we are going to be launching this drug you know as soon as possible I would say in the 2024 time frame"
In October 2022, the US Food and Drug Administration (FDA) issued 3 guidance documents for industry, including final guidance on acute myeloid leukemia (AML) drugs and biologic products. This document was originally published in draft form 2 years ago and was updated to address comments received on the draft guidance.
6) Is Sellas Life Sciences considered a direct competitor to Actinium Pharmaceuticals? Is there unarticulated risk due to prior Actinium employees working at Sellas and holding patent rights?
Context: Dragan Cicic, former employee at Actinium Pharmaceuticals, is the CMO at Sellas Life Sciences and has patent rights to some of Actinium's technology.
7) Who was the direct competitor that Dr. Qing Liang violated the non-compete provision with?
Context: 2023 Proxy Statement, Trade Secrets section
8) Is Sandesh Seth a risk to the success of Actinium Pharmaceuticals given his prior employment with Laidlaw & Company UK Ltd, and the loss of Actinium's market capitalization since 2017 when Sandesh was appointed CEO?
Context: March 2024, Crain's Managing Partner James Ahern was named one of Crain's New York's Notable Leaders in Finance for 2024. Mr. Ahern has been at Laidlaw for fourteen years and is credited with the firm's strategic investments in some of the most promising and cutting-edge healthcare advancements to date. Mr. Ahern funded and brought Actinium Pharmaceuticals public, putting a total of $61 million into the company.
9) With the recent $10B+ collective M&A by Big Pharma for Ac-225 based companies and drugs in late-2023 to 2024, how will Actinium capitalized on Ac-225 boom and future drug demand for the isotope?