re: Diamond in the Rough - Humanigen ($HGEN) a little DD

quote:

---

UK’s MHRA accepts Humanigen’s submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review
BURLINGAME, Calif.Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), today announced its submission for Marketing Authorization for lenzilumab in COVID-19, begun in June 2021, has been accepted by the United Kingdom’s (UK’s) Medicines and Healthcare Products Regulatory Agency (MHRA) for expedited COVID-related rolling review, with assessment expected to occur more rapidly than a standard rolling review.

Leading up to initiating its submission for Marketing Authorization last month, Humanigen held meetings with various authorities in the UK, including a Rapid C-19 multiagency meeting with representatives from the MHRA, the Therapeutics TaskForce, (TTF), the Department of Health and Social Care (DHSC), National Health Service England (NHSE) and the National Institute for Heath and Care Excellence (NICE).

“We are grateful this submission will receive expedited consideration by MHRA,” said Cameron Durrant, CEO of Humanigen. “The global spread of variants of concern, such as the Delta variant, highlights the continued need for proven therapies that are variant-agnostic for millions who remain at risk of COVID-19.”

According to Public Health England, despite the first dose vaccination rate of 86% across the UK, the current seven-day hospitalization rate was nearly 2,500, representing a 45% increase over the prior period. Deaths from COVID in the UK reached 161 over the last seven days, an increase of more than 40% compared to the prior seven-day period.1

“We continue to work with our partners to prepare for distribution of lenzilumab pending conditional approval of its use to treat hospitalized patients with COVID-19,” noted Timothy E. Morris, COO and CFO of Humanigen. “In the event Emergency Use Authorization in the United States and Marketing Authorization in the UK are awarded concurrently or in parallel, we will work with the relevant authorities to ensure appropriate allocation of lenzilumab in each country.”

---