Agreed. To add to that, without US FDA and reimbursements in the US, they had no chance in hell to ever get back to a billion dollar market cap even with UK approval and potential NICE reimbursement in 2028. The margins and NICE/NHS budget in the UK just doesn’t support a rich billion dollar valuation.
Also, it’s worth noting that they are pivoting towards Direct & the in-licensed Roswell Park tech. What does that tell us - they don’t see L as the future and/or they believe US will not approve L. Otherwise they would have started BLA application and manufacturing preparations for L in the US. Also, as an extension to that, they would consider new combination trial with L and expansion in multiple indications since the infrastructure and processes are already built for L and they have a better understanding of its mechanism of action. And not to mention if UK approval was coming for L, it would just add more validation. They simply won’t put in the resources to get Direct online and try to set up manufacturing for in licensed Roswell Park tech in the US. Do that for that your own L first in the US rather than an in-licensed product that is still in the phase 2 trial, so you can submit BLA to the FDA!
So the logical answer is that L is likely going to get shelved or remain a boutique offering in the UK to keep shareholders on the hook. The worst case outcome is that they will announce the negative news (UK rejection) a month or two after the next major round of financing is done and dusted.
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