![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Wednesday, January 29, 2020 1:14:29 AM
I suspect the FDA has a fixed number of days to comment on the proposed SAP, lets say 60 days for discussion purposes. If they answer and want a change made on day 60, once the change is made and submitted, the clock goes back to 60 days for review. In a similar situation I've seen the FDA stall approval of drugs for well over a year, but ultimately the drug was approved.
To me, one of the worst things about the way the regulators operate is that they can question anything, at any time. As an example, lets say the SAP was made up of 50 sections and a change was requested in the 10th section. When that section was submitted and accepted they could comment on another section they'd previously accepted, perhaps multiple times. The delay can come in completely unrelated areas that previously were believed to be accepted. This simply shouldn't be permitted, but it is.
If it were up to me, after an initial review the regulators should sit down with the and either agree to the changes as modified, or actually make further changes where all are in agreement. Instead of taking many months it would take a few hours. Until such dynamic actions are agreed to by the FDA and other regulators, the time to acceptance of documents like the SAP is unpredictable. Hopefully they're about to be past the threshold where the regulators can comment, but until that occurs, nothing else can proceed.
Recent NWBO News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/03/2024 08:01:40 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/13/2024 08:01:24 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2024 09:06:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/08/2024 08:30:09 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/02/2024 02:42:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/30/2024 11:49:38 PM
- Biophma Announces Exclusive In License for Dendritic Cell Technology, Sending Shares Higher • AllPennyStocks.com • 06/17/2024 04:40:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 09:11:16 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 06/03/2024 09:22:55 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 05/22/2024 08:13:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/10/2024 09:04:57 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/01/2024 10:04:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/02/2023 01:31:35 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/16/2023 10:11:54 PM
- Epazz, Inc. (OTC Pink: EPAZ) ZenaDrone Demonstration to Defense Departments of UAE and Saudi Arabia • InvestorsHub NewsWire • 11/15/2023 12:19:31 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:30:39 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 • InvestorsHub NewsWire • 11/09/2023 01:00:34 PM
- Epazz, Inc. (OTC Pink: EPAZ) US Navy Collaboration ZenaDrone 1000 Extreme Weather Demo • InvestorsHub NewsWire • 11/07/2023 12:29:43 PM
FEATURED Mawson Finland Limited Expands Known Mineralized Zones at Rajapalot: New Lens Intercepts 21.75 m at 5.25 g/t Gold & 515 ppm Cobalt • Sep 4, 2024 9:02 AM
FEATURED Integrated Ventures Acquires 51% Stake In GetTrim.Com (TM), Telemedicine Platform With Focus On Expansion Into Booming GLP-1 Powered Weight Loss Market • Sep 4, 2024 8:45 AM
VAYK Confirms Receiving Revenue from First Airbnb Property with 1.4 Million Annual Revenue Goal • VAYK • Sep 4, 2024 9:34 AM
Avant Technologies Announces Strategic Review Process Intended to Maximize Shareholder Value • AVAI • Sep 4, 2024 8:00 AM
PickleJar Launches National "Get on the Bus" Campaign, Unveils Thompson Square Tour Bus Wrap • PKLE • Sep 4, 2024 7:17 AM
Maybacks Global and Inventel Products To Launch Global 24 Hour Shopping Channel • AHRO • Sep 3, 2024 9:15 AM