Totally agree. They are only a little vindicate when you blatantly defy them as they should be. They are regulators and that doesn’t just mean evaluating and approving, it means enforcing laws meant to keep charlatans from pushing snake oil or overstating efficacy, minimizing safety (that is a big one), and making comparison that can’t be made.
The last one is interesting to think about in the new world. Do we really ever need comparison studies in ndGBM? Now you need to prove your salt first in recurrent GBM, notice the recent companies path for new products, and if you do you may be allowed some day after a lot of long term experience you may be able to challenge DCVax. But not before then because Linda took us out very far to prove a point which will be very hard for others now to prove.
If you are all comparing to the same randomly captured, matched database that gets close to a defacto comparison.
Even when you do break rules they usually start small and get bigger and bigger if you just wont learn your lsson or you step way out of line. Premarket promoting a drug in review gives the market the impression the drug has been approved when it has not. Think about a drug with other indications, that could be downright dangerous. They try to be consistent too unless that is not really good for patients.
That is why you can only do it with their permission, a permission they don’t always grant. They too are interested in getting real advances in the bodies of patients as quickly as possible and a little ‘coming soon’ helps when you are pushing to get across a finish line where the race has already been called. Now lets say you are trying to remain stealth about it, then you choose the first path rather than the obvious second path by actually saying ‘coming soon.’. They give you a choice but you can’t do both or too much and they are watching. If you make innocent mistakes anytime, they handle you softly. But they do stop you.
That is the real value of the tote that gets mocked…it is rather stealthy and one that could just get a stinging slap. But the full page add is more and complete, because of that, the tote is confirmation of no slappy slappy has gone on.
It is only a tote…are you serious? Yes, quite serious actually because it came second.
AI
