Thoughts on Northwest Bio’s marketing application:
It’s a massive undertaking to develop a drug and bring it to market, even for a well-resourced, experienced pharmaceutical company that has commercialized many drugs. The difficulty is magnified tenfold, for a small company like NW Bio, that doesn’t have the resources or experience of Big Pharma, and is applying for its very first commercial marketing approval, for a novel cell therapy, that may not be well understood by regulators. It’s not only necessary to run clinical trials to prove the product’s safety and efficacy, but they must also prove their ability to manufacture the product consistently to meet very strict commercial standards in high volumes.
Northwest Bio owns ground-breaking, disruptive technology that one day may help to change the way cancer is treated, and I think It’s managed by some well-intentioned, accomplished people who truly care about helping cancer patients. But it would be a huge understatement to say that Northwest Bio’s management has underestimated the problems and opposition that confronts companies when bringing a disruptive cell therapy to market, as well as the time it takes to counter and overcome them. In my view, their credibility has been damaged by their numerous, inaccurate, often-extended timeline forecasts, half-truths, and repeated delays. I don’t think that necessarily makes them incompetent as some suggest, but the repeated attacks have probably made them wary of the slightest mis-step, and exposure to potential future attacks, which probably affects their actions and communication.
Northwest Bio has navigated and overcome numerous hurdles, and has many accomplishments. As a reminder, they: 1. produced positive clinical trial results, (from a trial with flaws) 2. got those results published in JAMA, 3. gathered evidence, and brought a suit against malicious stock market criminals who repeatedly manipulate their stock, 4. developed crucial manufacturing data, (which is necessary for a successful marketing application) 5. developed an automated, digitized system to manufacture their product, (which is necessary to overcome commercial bottlenecks) 6. gathered and analyzed data from decades-long clinical trials, and converted and digitized that data into a common marketing application, (that will also be used in the US and other jurisdictions) and are now very close to filing an application for their first regulatory approval.
The company had a pre-submission meeting with the MHRA, and is in contact with other regulators, as well as being advised by informed consultants and scientific board members, so if, based on the expert advice they received, they concluded that it was prudent to take an extra month or two, just prior to submitting the application, in order to gather additional data or evidence, that will strengthen the marketing application, (possibly required by the FDA) then how can I (or anyone else) disagree?
I think some of the wording used in the previous, Oct. 13th press release, (and their past history) made it seem unlikely, that NW Bio was going to achieve that very optimistic timeline of submitting the application by mid to late November. Last week’s update, that the publisher now has (most of) the key final section, the publisher’s work has begun, and it may take them several weeks to complete the application, is very positive news. (despite the “distorting” on social media, and coordinated stock “shorting” by hedge funds)
The next MHRA submission deadline is December 25th, which aligns with a CHM meeting on March 21st or 22nd. I’m fairly confident that they will submit the application next month, and beat this deadline.
