Roger,
Do you think Stemson chose U.K for its relaxed rules on medical trials and applications?
@Otter Yes I think that is likely and I think some of these companies may have hit unexpected hurdles with the regulatory process in Japan. Japan was supposed to be the best shot with its newly loosened laws but now it seems some of the researchers are having second thoughts about that.
I also think there’s a Brexit factor working in favor of the UK, since they’ve had to decouple from many trade opportunities in Europe, they’re more hungry for any investments and technology companies coming in from the US and other countries. So they may be rolling out the red carpet so to speak for more researchers to conduct clinical trials there.
Sounds exciting; however, I will get excited about this when I see hair growing on humans. Seeking less regulations may mean they really are on to something and want to avoid as many barriers as possible. It takes way too long for the FDA to approve anything.
This is bitter-sweet because it shows that things are progressing with Stemson’s technology but it will take longer to go through trials in UK than it would in Asia since Asia has sped up their approval process for cell-based treatments.
In Asia Stemson could have probably gotten their treatment to market in 1 - 2 years whereas in the UK it will likely take 4+ years.
Stemson is really on top of things -
https://www.thepharmaletter.com/in-brief/brief-faster-approvals-planned-for-post-brexit-uk
That is a smart business move. This sounds very promising. With our excessive regulations here, it takes millions ( $41,117 per patient). and at least 10 years or more to get it approved. If I had something that worked, I would do everything in my power to avoid the FDA. If it wasn’t for Trump, they would still be trialing the Covid vaccine.
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The article seems to indicate that Stemson still hasn’t decided which country to run their trials in. They seem to be saying that UK is a possibility but not a certainty.
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There is so much info about Brexit and Transition Periods and post-Brexit issues that I can’ get a handle on it. When is UKs faster approval process supposed to start taking place?
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If UKs faster approval process won’t start taking place for a couple more years Stemson would be much smarter to run their trials in Asia because the Asian system makes it possible to get a treatment to market after just 2 years of trials, and in some cases treatments can get to market in just one year.
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If Stemson starts human trials in Asia by Spring 2021 hey could market their treatment sometime in 2022 whereas the UKs faster new approval process might not even begin until 2022.
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I don’t know the specifics of the UK’s proposed new approval process. Asia’s approval process might still be faster even after UK adopts their new process. If the new faster UK approval process takes significantly longer than the Asian process I think Stemson would probably go with Asian clinical trials. The sooner they can get their treatment to market the sooner they can start generating revenue from it.
Sure, but simply inviting research companies to do their trials in UK isn’t going to get research companies to do their trials in UK. The main goal of the research companies is to make the biggest profits asap and that means in order for UK to start getting more clinical trials done in the UK they’ll have to be competitive with Asia’s speed of marketability. If you owned Stemson and Asia was offering to let you bring your treatment to market after a 1 year study whereas the UK wanted you to do 2 - 3 years of studies before getting into the market, which country would you conduct your trials in?
I think it’s a no-brainer that Asia still has the edge unless/until UK announces potential marketable within 1 year sometimes and 2 years at most, just like Asia.
Well said, it’s a no brainer doing the trials in Asia is the way to go.