Followers | 17 |
Posts | 936 |
Boards Moderated | 0 |
Alias Born | 04/26/2010 |
Thursday, September 20, 2018 1:38:55 PM
What does it mean that BTD for B-OM is still in play?
1. That we have management willing to announced milestone loan agreement based on getting BTD for B-OM by the end of September and then proceeds to sat on application until it was possible that FDA's response would not come in time?
Or
2. That the management filed for BTD well in time and got FDA's no cigar response with FDA's advice how to get the said cigar. Then went to work and refiled, presumably being sane enough to follow FDA's instructions?
Or
3. For some flabbergasting reason the potential BP stalled IPIX filing for BTD until FDA response was likely to be late for milestones?
If you think, as I do, that we have the case number 2, then there are some further speculative statements possible, including this:
Whatever was the FDA's reason for the original rejection it must have been something that the IPIX management thought fixable without additional clinical work.
Highly speculative, of course, but if correct, encouraging.
"I would rather have questions that can't be answered than answers that can't be questioned." Richard P. Feynman
Recent IPIX News
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 01:30:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/05/2023 09:25:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:05:44 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/15/2023 01:00:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/28/2023 01:00:08 PM
Green Leaf Innovations, Inc. Expands International Presence with New Partnership in Dubai • GRLF • Jun 24, 2024 8:30 AM
Bemax Inc. Positions to Capitalize on Industry Growth with New Improved Quality of Mother's Touch® Disposable Diapers • BMXC • Jun 24, 2024 8:00 AM
Last Shot Hydration Drink Announced as Official Sponsor of Red River Athletic Conference • EQLB • Jun 20, 2024 2:38 PM
ATWEC Announces Major Acquisition and Lays Out Strategic Growth Plans • ATWT • Jun 20, 2024 7:09 AM
North Bay Resources Announces Composite Assays of 0.53 and 0.44 Troy Ounces per Ton Gold in Trenches B + C at Fran Gold, British Columbia • NBRI • Jun 18, 2024 9:18 AM
VAYK Assembling New Management Team for $64 Billion Domestic Market • VAYK • Jun 18, 2024 9:00 AM