Replies to post #20980 on CytoSorbents Corporation (CTSO)

[B52T38]

Thanks, techxen. If what you state is true re: the FDA and how they think of medical devices, this puts Dr Chan in a tough spot. He needs the FDA to approve our product, so he has to make sure he doens't "upset" them, even if the whole country is locked down. They are the gatekeepers, and if he tries to go above their heads to the media or politicians, he will anger the FDA beast and they may just leave us swinging in the wind.

I would like to think the president could intervene, but he has so much on his plate, odds are slim. Also, we've seen the swamp can be very hard to drain, so unless it's a very direct and specific directive to do something,
i.e., approve our product, the swamp finds a way to delay, delay, delay.

Like the IRS, the FDA must be thoroughly revamped, if not flushed. It's become a kingdom of bureaucrats without any check, balance, or control.

[Aliberto]

I would like to reply to you. I believe that all governments, hospitals and regulatory authorities are currently taking all measures to limit the effects of the coronavirus in the best possible way. Governments in particular are currently taking unusual measures and are also accelerating certain processes with the regulatory authorities.

A good current example is provided by the German company Drägerwerk, which produces ventilators and high-quality respiratory masks for clinics. Drägerwerk usually receives its orders from the clinics and this has always been the case for the past decades. Now, on March 13, 2020, a huge order for 10,000 ventilators was received directly from the German government (i.e. from a government agency and not from a hospital group), and this was the largest order in the company's history.

Yesterday, the US government also placed a huge order with Drägerwerk, where respiratory masks were ordered in the tens of millions. Drägerwerk will shortly build a new production facility on the east coast of the USA especially for this major order. According to current plans, production will start operating in September! In my opinion, negotiations with the US government for several days or weeks had already taken place beforehand, and some land had been chosen and / or "bought or made available," otherwise a CEO of Drägerwerk would have never made such a statement with production start in September.

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So many discussions and negotiations with many providers from the medical sector are likely to be running in the background and this is and will be -in my opinion- also be the case with cytosorbents.