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Post by mango on Oct 23, 2018 11:03:27 GMT -5
I love it too! Exhale doubt. Inhale confidence. Very nice.
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Post by mango on Oct 24, 2018 10:22:51 GMT -5
Did a quick scan of Mr. Clover's writing.
The article is saturated in misinformation and demonstrably false statements and claims.
The guy is a clown.
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Post by mango on Oct 24, 2018 10:46:36 GMT -5
I would probably sue the FDA for the earned advertising on the grounds afrezza is not old school insulin but rather a superior meal time insulin based on the PK which allows for no drama. Have the FDA prove it is not. I will predict they can not. Since they won't give us the ultra on the label maybe the settlement will allow the word "Superior". You don't need to sue the FDA, just leave the advert up and they will start the fight for you. Unlike an untitled letter a warning letter is the start of an enforcement action, it's your chance to become compliant before this ends up in court. That's a losing proposition because you will spend a small fortune on external lawyers and consultants, execs who should be working on moving the company forward are diverted instead into the action, and prospective partners will avoid you. For all of those reasons your share price will drop until this is all over. Ultimately you lose anyway because there is a black box so by definition there is a risk of drama (likewise there are risks on the label.) In my experience of fighting government agencies settlements are around how little you can concede. They don't give you rewards like letting you improve the label as in your example. You don't pick fights with your regulator unless the threat is existential which it definitely is not in this case. DoJ and FDA have never once done anything other than issue a fine to people like Novo Nordisk, Bistol Myers Squibb, Sanofi, Mylan etc... Those companies don't just pick fights man, they blantantly rip off and steal from innocent people, the VA, spearhead evil, disgusting crimes, lie about their products in any form and fashion, bribe government officials, thought leaders, clinical investigators, etc...MannKind has done nothing. MannKind did not even make a false claim. A little logic and common sense is desperately needed in FDA.
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