For the U.S. FDA Patterson's plan is not just unr
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(Total Views: 587)
Posted On: 09/06/2021 8:48:51 PM
Re: Evil Rabbit #102607
For the U.S. FDA Patterson's plan is not just unremarkable but unworkable. The FDA has already said they want 700mg and are not interested in 350mg. If 350mg were submitted at this point they would need a whole new write up of the BLA.
The 13d are also willing to throw the Brazil trials out the window,
Their sole focus is longhaulers. I'm sure Bruce would think his protocol would be superior and any current protocol and even a running trial would be scrapped. Which would mean submission of new protocol and a wait on the FDA for it's approval after October.
Why would they scrap everything else and focus on longhaulers to the detriment of the company? So that Bruce could bask in the glory. I wonder if the 13d have any plans to withdraw the objections at the Patent office to Bruce's patent?
Focusing solely on one indication to the exclusion of others might be a perilous path to follow if there are any problems with their version of the longhaulers trial.
They say they have no plans to buy IncellDX even though they previously stated they were. So were they lying then or are they lying now.
The 13d are also willing to throw the Brazil trials out the window,
Their sole focus is longhaulers. I'm sure Bruce would think his protocol would be superior and any current protocol and even a running trial would be scrapped. Which would mean submission of new protocol and a wait on the FDA for it's approval after October.
Why would they scrap everything else and focus on longhaulers to the detriment of the company? So that Bruce could bask in the glory. I wonder if the 13d have any plans to withdraw the objections at the Patent office to Bruce's patent?
Focusing solely on one indication to the exclusion of others might be a perilous path to follow if there are any problems with their version of the longhaulers trial.
They say they have no plans to buy IncellDX even though they previously stated they were. So were they lying then or are they lying now.
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