Monday, October 15, 2007 12:32:10 PM
hello aiming4,
we have talked some about going up against the FDA, using the formal review process, and i never did find that article on what happened to the companies sited in the article, except it wasn't pretty.
there is a company, symbol DDSS, that posted just such an anoucement this morning:
9:26AM Labopharm appeals FDA's decision on once-daily tramadol (DDSS) 23.94 : Co announces that it has initiated the FDA's Formal Dispute Resolution process, appealing the Agency's decision regarding the co's once-daily formulation of tramadol. DDSS received a second Approvable Letter from the FDA for its once-daily formulation of tramadol in May of this year. The co firmly believes it has met the statutory standards for approval of its once-daily tramadol formulation.
http://finance.yahoo.com/marketupdate/inplay
Now when i first read that, I thought, good they are trying to stand their ground and do what's right. But the stock dropped to a new 52 week intraday low on the news.
Going against the FDA can be tough. Maybe it is some issue they can peacefully resolve, but it sounded pretty final when i read cor's news a few days ago.
i know very little about ddss, but found this news interesting and it may apply a little towards what cor is up against....
Recent RSPI News
- Form 8-K - Current report • Edgar (US Regulatory) • 09/06/2024 12:45:11 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/02/2024 12:30:23 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/08/2024 08:01:32 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/29/2024 01:03:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/02/2024 01:30:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/22/2024 01:45:38 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/11/2023 01:45:18 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/17/2023 09:06:03 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/14/2023 09:05:14 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/12/2023 01:00:21 PM
Transforming Alzheimer's Treatment: Innovative Combinations to Boost Cognition • PFE • Oct 2, 2024 9:00 AM
Unitronix Corp Unveils Cryptocurrency Investment Portfolio Strategy • UTRX • Oct 2, 2024 8:40 AM
Integrated Ventures, Inc Reports Total 2024 Revenues Of $5,863,935 vs $3,862,849 for 2023. • INTV • Oct 1, 2024 9:00 AM
Nightfood Signs Letter of Intent to Acquire Los Angeles Cooking School, Integrating Automation and Robotics with World-Class Culinary Training • NGTF • Oct 1, 2024 8:30 AM
ZenaTech, Inc. (NASDAQ: ZENA) To Commence Trading Today • COOP • Oct 1, 2024 7:00 AM
Element79 Gold Corp secures loi for launching tailings reprocessing business in Arequipa, Peru • ELMGF • Oct 1, 2024 6:38 AM