NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

gallium-68 (68Ga) gozetotide (a medicine for diagnostic use only to allow the imaging of prostate cancer). This medicine had its first CHM meeting on 4/25/24. It goes by the name Illuccix, and is owned by Telix Pharmaceuticals. It has been languishing in the process for a long time – this is the poor drug that had to wait a full year for its first meeting. Also, it is the one drug out of the 24 I looked at that publicly mentioned receiving its RFI. One single drug, out of 24. So next time someone tries to tell you it's unusual for a company not to PR updates, know that they are just making that up. And if you are one of the people here clamoring all day every day about the company's "unusual" or "suspicious" strategy regarding communications about this process, know that you are wrong, and everyone here knows you are wrong

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13 Jan 2025

MELBOURNE, Australia and INDIANAPOLIS, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today provides an update on its commercial and operational performance for the quarter ended 31 December 2024 (Q4 2024)

Illuccix® global regulatory submissions: The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, or BfArM) is expected to provide its decision on the Company’s EU marketing authorization application on 15 January 2025. In the United Kingdom (UK), the Company has responded to all queries with no substantive issues raised. The UK regulator (the Medicines and Healthcare products Regulatory Agency - MHRA) is experiencing significant administrative delays but an approval decision is expected this month. The Brazilian Health Regulatory Agency (ANVISA) is expected to provide a decision imminently after protracted administrative delays also unrelated to Telix’s marketing authorization application.

https://ir.telixpharma.com/news-releases/news-release-details/telix-exceeds-fy24-guidance-us142m-q4-revenue-0

18 July 2024

Telix is expecting to receive a regulator’s assessment report by the end of July 2024 from the UK Medicines & Healthcare Products Regulatory Agency (MHRA)

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22 August 2024

The UK Medicines & Healthcare Products Regulatory Agency
(MHRA) regulator's assessment report has been received with no substantive issues raised. Decisions expected in H2 2024

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