Tuesday, April 15, 2014 10:18:28 AM
I've got a small position only been here a few weeks. I learned about the stock through Crookedneck. I am looking to add more when I have cash freed up. I never carry more than a couple penny stocks at a time so this and NRTI are it for now.
I would certainly never say '510(k)s' are simple. In fact in many ways they can be more nerve wracking than PMAs.
While PMAs are typically longer and have more requirements the process is 'on rails' PMAs can be more predictable which investors like. Because less guidelines in a 510(k) process around what is required to prove safety and efficacy 510(k) clearance can have many more point battles and variability it in timeline. I can't state how it would affect investors, what would probably be the most negative is if they went 510(k) but were forced into a PMA. Starting out on the PMA path might not be the worst. (100% opinion, and only a educated guess at that)
Remember the 510(k) process is a 'substantial equivalence' process. You are proving your device is equivalent enough to a device already cleared in the 510(k) database it terms of safety. You still have to do all the bench testing, verification and validation and clinical trial (not for every medical device but in this case I'm sure it will be needed) as part of the submission package.
Let's think why this would be a PMA. The FDA might call it class III due to the fact this is directly going into the blood, therefore if their was a contaminant a patient could get hurt easily and they deem the risk high enough. Another reason would be: nothing to compare it to in the 510(k) database. I don't think so though unless they state the filtration technology is so divergent from other filters it is not comparable.
My opinion is still a class II and a 510(k) through CBER. So 9-12 months once submitted.
If we lucky 510(k) through CDRH and 6-9 months.
Reminder:
510(k)s are 'cleared'
PMAs are 'approved'
(Us Regulatory types have to correct folks all the time, especially marketing but it's an important distinction.)
Recent CTSO News
- CytoSorbents to Present at the H.C. Wainwright 26ᵗʰ Annual Global Investment Conference • GlobeNewswire Inc. • 08/27/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/20/2024 08:51:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/16/2024 10:58:42 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 08/16/2024 10:57:45 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/16/2024 09:28:33 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/16/2024 09:12:04 PM
- CytoSorbents Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 08/16/2024 08:05:00 PM
- CytoSorbents Reports Second Quarter 2024 Financial and Operational Results • GlobeNewswire Inc. • 08/13/2024 08:19:55 PM
- CytoSorbents Appoints Peter J. Mariani Chief Financial Officer • GlobeNewswire Inc. • 08/13/2024 08:18:28 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 08:04:32 PM
- CytoSorbents to Report Second Quarter 2024 Operating and Financial Results • GlobeNewswire Inc. • 08/07/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/01/2024 08:12:56 PM
- CytoSorbents Announces Compliance with Nasdaq Minimum Bid Price Requirement • GlobeNewswire Inc. • 08/01/2024 11:00:00 AM
- CytoSorbents Unveils Newly Redesigned, Unified Company and Product Website • GlobeNewswire Inc. • 07/29/2024 12:00:00 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 07/26/2024 09:14:03 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/26/2024 09:11:21 PM
- CytoSorbents to Present at the Inaugural American Association of Physicians of Indian Origin (AAPI) World Health Congress • GlobeNewswire Inc. • 07/17/2024 11:00:00 AM
- CytoSorbents Secures $20 Million Credit Facility • GlobeNewswire Inc. • 07/02/2024 11:00:00 AM
- CytoSorbents Announces Regulatory Approval of CytoSorb® in Taiwan • GlobeNewswire Inc. • 06/24/2024 11:00:00 AM
- CytoSorbents Announces the Launch and Immediate Availability of the PuriFi™ Blood Pump in the European Union • GlobeNewswire Inc. • 06/13/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/10/2024 08:31:20 PM
- CytoSorbents to Host its 2024 Virtual Annual Stockholders Meeting • GlobeNewswire Inc. • 06/05/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/22/2024 08:35:12 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 09:23:00 PM
- CytoSorbents Reports First Quarter 2024 Results • GlobeNewswire Inc. • 05/09/2024 08:17:23 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM