Followers | 20 |
Posts | 5544 |
Boards Moderated | 0 |
Alias Born | 01/04/2012 |
Saturday, March 11, 2017 12:45:07 PM
Steps to Re-Commercialization
Regulatory
?? Meet with FDA to initiate re-activation of NDA(s)
?? CMC – provide documentation to justify any changes to site, suppliers,
DMF
?? Drug substance/drug product – demonstrate similarity to product
manufactured under approved NDA
?? Label – match H.P. Acthar® gel indications, excluding Infantile Spasm
?? Filing type – sNDA as prior approval supplement
Quality
?? Utilize modern methods to characterize active pharmaceutical ingredient (API) - (In progress they have to run sequential batches and test for stability. I Don't know how long this will take to complete)
Supply chain
?? Secure partner for API and sterile manufacture (DONE)
Corti presentation
DMF and Regulatory process they hired:
and
They are apparently ahead of schedule. I don't know how far ahead.
They obviously have experienced people in place so I believe they will have all the ducks properly lined when they meet with the FDA
The sNDA takes on average 6 Months to review vs the 10 month NDA.
I think everything gets completed including FDA approval some time in 2018.
JMHO
Recent ANIP News
- Form 8-K - Current report • Edgar (US Regulatory) • 09/20/2024 08:03:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/16/2024 08:50:53 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/16/2024 01:13:56 PM
- ANI Pharmaceuticals, Inc. Completes Acquisition of Alimera Sciences • GlobeNewswire Inc. • 09/16/2024 12:53:27 PM
- ANI Pharmaceuticals Initiates Closing of Acquisition of Alimera Sciences • GlobeNewswire Inc. • 09/16/2024 10:50:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/13/2024 08:23:15 PM
- ANI Pharmaceuticals Launches Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution • GlobeNewswire Inc. • 09/13/2024 10:50:00 AM
- ANI Pharmaceuticals and Alimera Sciences Announce Closing Date of Merger • GlobeNewswire Inc. • 09/11/2024 10:50:00 AM
- ANI Pharmaceuticals and Alimera Sciences Announce Closing Date of Merger • Business Wire • 09/11/2024 10:50:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/10/2024 08:44:38 PM
- ANI Pharmaceuticals Provides Update on Closing of Acquisition of Alimera Sciences • GlobeNewswire Inc. • 09/10/2024 06:09:55 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/14/2024 12:29:49 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/13/2024 08:21:44 PM
- ANI Pharmaceuticals, Inc. Closes $316.25 Million Convertible Senior Notes Offering Including Full Exercise of Initial Purchasers’ Option to Purchase Additional Notes • GlobeNewswire Inc. • 08/13/2024 08:05:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2024 01:51:52 AM
- ANI Pharmaceuticals, Inc. Prices Upsized $275.0 Million Convertible Senior Notes Offering • GlobeNewswire Inc. • 08/08/2024 01:44:18 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/07/2024 11:26:24 AM
- ANI Pharmaceuticals, Inc. Announces Proposed Convertible Senior Notes Offering • GlobeNewswire Inc. • 08/07/2024 11:00:55 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/06/2024 10:57:57 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/06/2024 10:53:07 AM
- ANI Pharmaceuticals Reports Second Quarter 2024 Financial Results and Raises 2024 Guidance • GlobeNewswire Inc. • 08/06/2024 10:50:00 AM
- ANI Pharmaceuticals to Discuss Second Quarter 2024 Financial Results on August 6, 2024, at 8:30 a.m. ET • GlobeNewswire Inc. • 07/31/2024 11:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/19/2024 09:30:14 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/19/2024 09:27:27 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/18/2024 09:12:40 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM