I agree in large part with this, but I don’t think the delays are simply the result of management not needing the money because they old and lazy and rich and don’t care and would rather leave it to their heirs ;)
IMO the delays have to do with multiple factors, not all of them nefarious. IMO this is the main factor:
Almost all of the delays in the trial and post data lock events relate directly to INCREASING the chances of regulatory approval (OS primary endpoint, external controls, adjudication/advancements in detection of pseudo progression, long tail survival data, waiting for updated RA guidance, manufacturing certifications, manufacturing improvements/cost saving, manufacturing buildout/scale, publication in a top tier journal, having thorough and well vetted regulatory applications, etc.)
In short, management is ensuring the treatment has the greatest chance of being approved at the expense of time.
While this certainly hurts the thousands of patients that die because treatment approval is delayed, the counter argument is that if they had rushed the process (eg applied for approval without external controls) there is a high chance that it would be rejected by all 4 RA’s and NOBODY would benefit.
It’s a cruel analysis that many long suffering shareholders are quick to dismiss because TRUST ME it hurts to be invested in a science that you believe in for years while you lose a massive chunk of your lifetime savings… but there really is no other explanation unless you think management is just collecting a salary/bonuses and building up/selling of CDMOs on the back of a GBM treatment the know will fail.
For me (once I see past my frustrations) the SAP, external controls, Flaskworks acquisition, TLD, MIA, PIP, filing in the UK first, and most of all publication in a top tier journal PROVE that management is doing everything it can (against significant impediments) get this novel biologic treatment to market.
Unfortunately due to a multitude of factors our perceptions of reasonable timelines, our investments, and most importantly GBM patients will suffer until that happens.
BTW I’m not giving management a pass at all. I just don’t buy in to the narrative that they are intentionally causing delays because they know the treatment doesn’t work and are simply delaying its inevitable rejection. Quit the contrary, the delays are exponentially increasing the chances of regulatory approval.
Bullish
