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Re: None

Tuesday, 07/23/2024 12:03:49 PM

Tuesday, July 23, 2024 12:03:49 PM

Post# of 731108
Also important to keep in mind, how long new regulatory guidance took to establish RWE as viable, and or even preferable, from an ethical perspective for severe disease trials, which helps the recruiting efforts to enroll trial participants. Also keep in mind, that it was the regulators who required the crossover.
- These external interventions are fundamentally responsible for adding more years than longs originally expected.
- It took an equal amount of time for Bosch et al to evolve and mature processes and methods to ensure viability.
- All these efforts on the formulation end took all this time to secure critically important IPs. The last thing they need is to face infringement by would-be copycats and drawn out legal cases.
- Keep in mind that Flashworks was acquired, I believe some time near DL. It wasn't NWBO management, but rather the folks at Flashworks, who worked independently to modify and evolve Eden all this time. Until recently, Flaskworks was still tweaking a couple of newer prototypes, and hadn't finalized the commercial version yet, but were very close. LP has been dead on accurate, when she describes multiple fronts working in parallel.
-Add the brutally inept inefficient bureaucracies, RA's, and counter parties, which have large rolls to play.
Lastly, there have been supply chain issues, which haven't completely resolved, and that brings you to where we are today. Imo, one can argue in no less time than it should have taken.
So we can talk about Jama taking long or the MAA application, but that narrow minded view ignores the total sum of all the parts working in tandem. Anyone can tease out what they want to make misleading statements, but give some people credit for critical thing.
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