Tuesday, June 18, 2013 6:52:41 AM
Cotara has PIII design approval, Fast Track, orphan drug status in US and Europe and is given an early exit opportunity on intermediate data for its 300 patients clinical trial.
Besides that Cotara is very well tolerated, needs on a single one shot treatment and according to SK (presentation slides) it will be priced very competitive compared to SOC.
NWBO has no fast track, that means (assume they indeed enroll completely in H1/2014 and come up with results mid/end H2/2014) then 2 years on average must be added for FDA approval/refusal. Cotara with the fast track qualifies for the 6 month short procedure and doesn't need to enroll all 300 patients compared to NWBO's 312 patients.
Last but not least with the orphan status of Cotara comes marketing protection in the US and Europe, which NWBO doesn't has!
So in practice this is a race PPHM should win hands down. Let's see how management plays this!
Peregrine Pharmaceuticals the Microsoft of Biotechnology! All In My Opinion. I am not advising anything, nor accusing anyone.
Recent CDMO News
- Form 8-K - Current report • Edgar (US Regulatory) • 10/17/2024 08:45:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/15/2024 11:40:21 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/11/2024 11:38:34 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/11/2024 11:38:08 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/11/2024 11:37:48 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 10/11/2024 12:22:11 AM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 10/11/2024 12:21:22 AM
- Avid Bioservices to Participate in Craig-Hallum Bioprocessing Conference • GlobeNewswire Inc. • 09/12/2024 08:05:27 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 09/09/2024 08:43:56 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/09/2024 08:19:30 PM
- Avid Bioservices Reports Financial Results for First Quarter Ended July 31, 2024 • GlobeNewswire Inc. • 09/09/2024 08:05:31 PM
- U.S. Futures Rise Amid Inflation Report Anticipation; Oil Prices Climb on Hurricane Threat and Supply Concerns • IH Market News • 09/09/2024 10:09:14 AM
- Avid Bioservices to Report Financial Results for First Quarter of Fiscal Year 2025 After Market Close on September 9, 2024 • GlobeNewswire Inc. • 09/03/2024 08:05:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/29/2024 08:30:10 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 08/28/2024 08:34:04 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 08/28/2024 08:32:18 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 08/28/2024 08:30:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 11:50:20 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/16/2024 11:48:19 PM
FEATURED North Bay Resources Announces Assays up to 9.5% Copper at Murex Copper Project, British Columbia • Nov 4, 2024 9:00 AM
Rainmaker Worldwide Inc. to Assume Direct, Non-Dealer Sales of Miranda Water Technologies in U.S. and Mexico in First Quarter of 2025 • RAKR • Nov 4, 2024 8:31 AM
CBD Life Sciences Inc. (CBDL) Launches High-Demand Mushroom Gummy Line for Targeted Wellness Needs, Tapping into a Booming $20 Billion Market • CBDL • Oct 31, 2024 8:00 AM
Nerds On Site Announces Q1 Growth and New Initiatives for the Remainder of 2024 • NOSUF • Oct 31, 2024 7:01 AM
Innovation Beverage Group Receives Largest Shipment of its Top-Selling Bitters to Date in the U.S.-Ready to Meet Growing Demand from Expanding Distribution Network • IBG • Oct 30, 2024 12:22 PM
Element79 Gold Corp to Update Investors on the Emerging Growth Conference on October 31, 2024 • ELMGF • Oct 30, 2024 9:08 AM