While the last 2 years have been a roller coaster for Maryland-based vaccine maker Northwest Biotherapeutics — highlighted by a $250,000 fine from the SEC, years operating as a penny stock player with big questions about a cancer drug years in a pivotal study — the biotech says it is still moving ahead with its expansion plans in the UK.
Northwest filed its application for a license to produce at its newest Sawston site, where the first phase of the facility has been built out and the next step will include an on-site inspection by the Medicines and Healthcare Products Regulatory Agency.
So long as a license is issued, production at the facility could start by the end of Q3, the company said in a statement. The facility will manufacture DCVax-L, an investigational therapy for patients suffering from glioblastoma multiforme, a type of brain cancer. Analysts, though, have questioned why the drug has spent years in a pivotal trial and whether it has any kind of viable future.
Northwest Bio’s facility in Sawston is blueprinted at 88,345 square feet on two floors with initial production capacity covering two manufacturing suites with about 4,400 square feet on the ground floor. Thirty employees have already been hired to operate the first two production suites, and the team will now expand with the manufacturing capabilities.
In 2019, the company announced that they reached a settlement with the SEC and agreed to pay $250,000 to close claims concerning “past weaknesses in its internal controls.” As part of the deal, Northwest didn’t admit guilt.
The company publicly disclosed material weaknesses in its Forms 10-K over the course of 12 years, starting in 2007, according to the SEC. In nine of those years, the company disclosed that it lacked the proper controls in place to ensure that all the material transactions and developments impacting financial statements were properly recorded.
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