Thursday, April 03, 2014 1:36:14 AM
Fast Track also makes the drug eligible for Accelerated Approval and Priority Review. There is also compassionate use. And the results achieved in the compassionate use program can be used to: support the NDA, identify new diseases or conditions for which the drug is efficacious, and/or inform/design future FDA trials. When the drug is proven safe AND efficacious in Phase 1, there is no reason not to get it approved for compassionate use. Once it is actually used to get people off that "death row" liver transplant list, I suspect thing will move pretty fast.
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm
http://www.fda.gov/newsevents/testimony/ucm115209.htm
bradfor123 said...
Recent GALT News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/20/2024 05:55:08 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2024 11:55:18 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 11:50:43 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/04/2024 05:50:30 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:55:59 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:53:47 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:52:32 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:51:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:50:02 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:48:42 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:47:36 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:46:30 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:44:42 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:43:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:40:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/16/2024 04:23:48 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/02/2024 01:07:50 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/18/2023 01:41:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/11/2023 09:15:23 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/07/2023 04:42:44 PM
- Form 5 - Annual statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/01/2023 09:50:50 PM
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 12/01/2023 09:38:34 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/01/2023 01:05:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/15/2023 10:19:22 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 11/13/2023 02:21:40 PM
Glidelogic Corp. Becomes TikTok Shop Partner, Opening a New Chapter in E-commerce Services • GDLG • Jul 5, 2024 7:09 AM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM