Wednesday, March 21, 2012 10:09:17 PM
The company was not in compliance by marketing in the US while in the applied-for stage at the FDA. No criticism from the negative posters for that.
Then came the normal warning letter from the FDA, with which the company immediately complied.....No problem there, but the negative posters were critical. Warning letter, compliance, professional.
The company must not market in the US until it has FDA approvals in-hand, so posters now complain they are doing so elsewhere. I've spoken today with some people who know exactly what goes on and they say the FDA approval for BIEL's additional products will be like the Holy Grail. They also advise that by establishing trade relationships globally the company will be in a beautiful position to move once the overseas parties see the FDA approval.
The company has had FDA approval for 8 years plus/minus on RecoveryRx for post-op eye surgery patients by prescription. If the FDA denies approval on ActiPatch and ALLAY, is that to say they erred on issuing the previous approval on RecoveryRX. The FDA is not made up of morons, but highly intelligent professionals.
Why are so many pounding on the company, which is taking the brilliant path many have complained they did not previously - that is to remain patient and silent, thereby professional?
I wait patiently, I buy more shares at basement prices, as I can afford to, while the FDA does what it needs to do in the order it decides internally it will do things. I won't be buying shares at 25 cents. All the whining in the world will not change the FDA approval process. Stay silent management, you have my respect for doing so and your ActiPatch worked unbelievably for me.
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