It’s a no-contest situation. Two years without MAA approval and no other regulatory filings is undeniable proof of how incompetent Linda Powers and her company are. Are we really going to keep using the excuse that DCVax-L is so “complex” that every single step must take not months, but years to complete? Stop being in denial—LP doesn’t want to submit a BLA to the FDA. If she did, that would’ve been her first move. Instead, she chose the MHRA route, and two years later, there are still no other filings.
Hands tied with MHRA? Absolutely not. They used third-party contractors for the MAA submission, so they could just as easily use them for the FDA or other regulators. Yet they haven’t. Instead, they’ve demonstrated nothing but incompetence. It’s not hard to put 2 and 2 together. How can anyone call them competent when, in two full years, they’ve achieved nothing?
Being “laser-focused” on the MAA to the point of ignoring every other path isn’t focus—it’s incompetence. Twist it however you want, but if you can only do one thing, and even that drags on for years, that’s incompetence, plain and simple. But of course, pumpers will keep defending their boss’s failed actions and decisions.
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