It seems Joan and I are in agreement.
A company submits a label, sees comments by 30 days, responding to those comments can be substantial effort and compromise, then a company resubmits label with supporting response, by 30 days FDA returns with comments. Companies can fold or try again.
Companies know the basics of their label well in advance of getting a label. Companies that get very difficult responses for good reason are the ones waiting on pins and needles as to whether it will be thumbs up or down. Most know the outcome but can’t say.
Some people in some companies are privy to some of these deliberations. The list is controlled, but not as controlled as you might think. The fear of God is placed on anyone with any knowledge. They are forced to sign a very threatening non-disclosure which very clearly remind them what constitutes insider trading. People think leaks happen…they don’t.
I speak from experience. My faith is placed in Dr. Linda Liau. Complete faith as she has shown us her soul. I believe in Linda Powers. She has been David leading a small force against Goliath and his army. She has gotten us to the end without going under and actually stronger than ever. I believe in Sashi Murthy and recognize that he was the secret to finding the Great Glass Elevator, and all or our chocolate and fizzy lifting drink Dendreams will come true. I believe in Marnix Bosch. He is smart and has guided the ship through regulatory waters unknown. He is Leif Erickson landing on North America long before anyone else from Europe would.
I speculate. I defend my theories. I share my equations and analysis freely. I am not paid by anyone for anything about this stock or any stock. I am not your financial anything. Make your own financial decisions or seek licensed professional help. I am not your anything, clinician, therapist, attorney, or anything else. I am not offering anyone here any advice, I am emptying my brain of thoughts in mostly stream of consciousness. I am hiding behind an avatar. You should not trust everything you read on this blog. You should do your own due diligence or seek licensed professional support, and make your own decisions about this stock or any other stock.
A company waiting on a regulator that gave them the green light to premarket promote and therefore went dark on everything else that even sniffs of breaching a mandatory quite period, one that pulls it’s booths once the Branded Advertisement begins but now has a giant booth and Promotional Product Theater knows the answer before it comes. They can release a paper before they get their answer from he regulator, whichever they may be.
