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Sunday, 04/24/2022 8:47:37 PM

Sunday, April 24, 2022 8:47:37 PM

Post# of 2794
Topline data is expected in Q3 of 2022. In other words, as early as sometime in July. After that the approval process may be beneficially affected by the fact of Orphan Drug Designation. As the April 12 press release stated...
"Iomab-B has been granted Orphan Drug Designation from the U.S. FDA and the European Medicines Agency (EMA). Iomab-B also has patent terms extending to at least 2036/2037 in the US and EU. In addition, Actinium received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application."
As the current partnership is for Europe and the Middle East the EMA approval may be the most important as future milestones and royalties will first flow from that partnership. Investors should anticipate some nice gains going into next year.

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