Replies to post #5046 on CytoSorbents Corporation (CTSO)

[BuyMyAsk]

Yes your credentials certainly do boost your opinion. What is your position in the stock? Long how many shares, at what price and how long have you been following?

I am under the impression this is going to go the PMA route and that is why Dr. Chan has not made too much mention about 510(K) process. Obviously they are 2 completely different routes. PMA is very difficult and 510(K) is fairly simple. News they are applying for 510K will shoot the stock up and news of PMA will send it down.

[PJO]

Thanks for the explanation of the diffrent process. You have Educated me and I suspect others Thanks

[ping_pow_princess]

The company has publicly stated that they plan to run a pivotal trial to gain approval in the US. It will go through a PMA process because it is a high risk device under Class III. The costs associated with PMAs are high because of the clinical trial that needs to run. (The application cost alone from the FDA is approx 65K for small businesses or 250K for larger businesses.) Additionally, I'm not sure what the exact plans are, but they intend to run more than the 2 studies (US approval + the US air force) that have been publicly stated in the country of United States. We should hear more about that later.

[crookedneck]

Good info PM, I appreciate your insight here. Next week on the 14th AH's they will report 1st qtr earnings and I think we will continue to see sales increasing qtr over qtr. Cheers!