Followers | 39 |
Posts | 2870 |
Boards Moderated | 0 |
Alias Born | 12/06/2003 |
Thursday, August 02, 2018 4:05:11 PM
If Premvia has a 510K CLEARANCE, how long is this doctor's study to take, when will his report be released...
As I read the PR, BTX has clearance to market premvia and the doctor's study may be accretive:
From the FDA:
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.
https://tinyurl.com/yb8rh6we
On the left side of the above link is an extensive listing of approvals which I wasn't up to reading trusting BTX not to have lied to me.
I have seen no hints of sales or negotiations for sales of Premvia (which is essentially the same as Renavia) so imagined BTX wanted or needed more extensive utilization for marketing.
As for the time the doctor will take for his study, I would expect the time will take from here to eternity before the paper shuffling begins.
I would love to give you a more definitive answer but I ain't no Time Lord like Dr. Who, who doesn't exist. All know is it nearly always takes longer.
Longer than what? Longer than my patience to keep watching.
Renevia will take longer too I would estimate.
Best, Terry
Recent LCTX News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:05:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:05:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:05:26 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 03/07/2024 10:17:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 09:10:09 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/15/2024 10:27:49 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/13/2024 02:30:12 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/13/2024 02:27:33 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 12:00:09 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/08/2024 11:58:18 PM
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 02/08/2024 11:57:07 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 02/06/2024 02:25:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/06/2024 02:20:38 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 02/06/2024 02:00:23 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/03/2024 12:08:49 AM
- Take Part in the Next Generation of Spinal Cord Injury Treatments with These Companies • AllPennyStocks.com • 11/16/2023 09:21:00 PM
- Take Part in the Next Generation of Spinal Cord Injury Treatments with These Companies • AllPennyStocks.com • 11/16/2023 09:21:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 11/13/2023 09:19:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/09/2023 09:10:32 PM
- Small Company Working on Big Breakthrough in Treating Spinal Cord Injuries • AllPennyStocks.com • 10/11/2023 02:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/07/2023 09:01:43 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/10/2023 08:16:11 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/10/2023 08:10:12 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 07/27/2023 08:15:41 PM
FEATURED Glucotrack Announces Expansion of Its Continuous Glucose Monitoring Technology to Epidural Glucose Monitoring • Apr 17, 2024 8:00 AM
ILUS Provides Form 10-K Filing Update • ILUS • Apr 17, 2024 9:54 AM
Maybacks Global Entertainment To Fire Up 24 New Stations in Louisiana • AHRO • Apr 16, 2024 1:30 PM
Cannabix Technologies Begins Certification of Contactless Alcohol Breathalyzer, Re-Brands product series to Breath Logix • BLOZF • Apr 16, 2024 8:52 AM
Kona Gold Beverages, Inc. Acquires Surge Distribution LLC from Loud Beverage Group, Inc. (LBEV) • KGKG • Apr 16, 2024 8:30 AM
Branded Legacy, Inc. Reports Significant Net Income of Over $3.8 Million • BLEG • Apr 16, 2024 8:30 AM