NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

By the way, this is kinda interesting on the subject:

150 days from completed application to approval

From FT:

Kate Bingham urges fund managers to step up investment in life sciences

The former head of the UK’s Vaccine Taskforce said the British regulator’s ability to move nimbly during the pandemic is luring new biotech companies to the country, as she unveiled her first major investment since returning to the private sector.

Kate Bingham will chair EyeBio, a biotech company founded by two American ophthalmology pioneers who are choosing to establish their group in the UK. The company is seeking to find new approaches to the huge unmet need of treating diseases causing blindness.

“We’re building the team here so that we can run the clinical trials here,” she said. “We’ve got a really flexible, friendly regulator that will allow us to generate that data quickly, which will then define whether or not the approaches we’re taking will work or not.”


Bingham, who has returned to her job as managing partner at London-based fund manager SV Health Investors, said the speed of regulatory decision making and clinical trials during Covid “put us on the map”. The Medicines and Healthcare products Regulatory Agency was the first regulator to approve a Covid-19 vaccine and the country’s Recovery Trial discovered treatments used around the world.

The UK is trying to attract more life sciences investment post-Brexit, with the newly independent regulator establishing an initiative to cut the time it takes to get treatments approved. For drugmakers granted the special status, the regulator will review data on a rolling basis and deliver a decision within 150 days of the final submission.

“I absolutely believe that the MHRA has to carve out a different niche compared with EMA [European Medicines Agency]. It can’t just be identical to what the EMA is doing. Because otherwise why would anybody ever apply to the UK or the MHRA?” she said.

Bingham also called on City of London pension managers to improve funding of life sciences venture capital, pushing back against a “prudent man approach” that she believes is constraining investment.

Investors in the UK have traditionally been cautious about funding riskier early-stage biotechs, the vast majority of which list on the Nasdaq. But a recent sell-off in biotech stocks in the US has seen many generalist investors retreat from the sector.

Bingham said she was not surprised by the pull back because it was clearly “not a good thing” when companies that have not yet begun trials in humans are going public.