NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Fexapotide Triflutate (the submitting company seems to have gone through some kind of bizarre corporate crisis recently which appears to have delayed their application in another jurisdiction, so that may have happened with the MRHA application as well)

July 16, 2024

Nymox Pharmaceutical Corporation (“Nymox”)

The Company's MAA to MHRA in the U.K. is in the active process of responses to questions received from MHRA. Nymox will update later in the cycle when appropriate

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Nymox Pharmaceutical Corporation (“Nymox”) (OTC Markets NYMXF) announced today that its MAA submission to the Danish Medicines Agency (DKMA) has run out of time and in order to continue will be required to extend the MAA application to DKMA by re-submission with a new fee required. As it currently stands the application “does not meet the conditions of the Medicines Act for issuing a marketing authorization.” Although a great number of questions were resolved by the Company, there remain further responses required that will require additional cycle time.

https://www.globenewswire.com/news-release/2024/07/16/2913880/10918/en/Nymox-Required-to-Resubmit-Application-to-DKMA.html
Nymozarfex is the brand name for fexapotide triflutate, a pro-apoptotic protein developed by Nymox Pharmaceutical Corporation for the treatment of benign prostatic hyperplasia (BPH).

SUMMARY OF THE COMMISSION ON HUMAN MEDICINES MEETING HELD ON
THURSDAY 30TH AND FRIDAY 31ST MAY 2024
LICENSING
NEW DRUGS (not previously licensed in the United Kingdom)
The Commission considered and advised on:
• a medicine used to treat adult patients with a type of liver disease known as primary
biliary cholangitis (PBC) which can get gradually worse over time and without
treatment may eventually lead to liver failure. It can also reduce itching that is linked
to PBC.
• a medicine used to treat men with an enlarged prostate (benign prostatic
hyperplasia, BPH[)?/b]

https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4/file/1722460230204