Replies to post #34015 on Humanigen Inc (fka HGENQ)

[DonDonDonDon]

This is done in a 60+40 day phases.

The 100 day review period is for regular applications. Expedited review can be much quicker. But there is no set amount of time. Sometime in November or December is likely what we are looking at. My guess is November.

[cowtown jay]

In terms of a UK authorization, we see the following time it took for Moderna's vaccine approval.

"...The decision from the MHRA is based on a rolling submission of data that was announced on October 27, 2020...

United Kingdom Medicines and Healthcare products Regulatory Agency Authorizes Use of COVID-19 Vaccine Moderna
January 8, 2021..."

So about 2.5 months.

https://investors.modernatx.com/news-releases/news-release-details/united-kingdom-medicines-and-healthcare-products-regulatory

In Humanigen's case, we have:

"UK’s MHRA accepts Humanigen’s submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review
July 09, 2021"

So, it's been 3.5 months so far.

https://www.businesswire.com/news/home/20210709005032/en/UK%E2%80%99s-MHRA-accepts-Humanigen%E2%80%99s-submission-of-Lenzilumab-for-Marketing-Authorization-in-COVID-19-for-expedited-rolling-review