Saturday, September 24, 2016 8:07:58 AM
NOV: FDA NDA submit, announce new device, new sales report
1. A new cold temp dispensing device, with longer out of fridge shelf life (7 days), is shipping and replacing inventory in EU.
2. Ferring, a smaller more committed to Vitaros company like Majorelle, has taken over the Takeda, Sandoz and Latin America territories, and will start selling again in the EU, the Germany launch is important, Germany has officially been transferred to Ferring:
Aug. 10th - “ the transfer of the German marketing authorization to Ferring, a critical step in Ferring’s plan to re-launch Vitaros in this important market, has been completed,” said Richard Pascoe, Chief Executive Officer of Apricus. “Moreover, this marks the first in a series of marketing authorization transfers we anticipate will occur later this quarter(Q3) as Ferring looks to further expand the availability of Vitaros in Europe.”
3. Latin America - Approval in Argentina is in, registration in Mexico and Columbia are in, both should be approved in 2016 -then Brazil for Ferring.
4. NDA in USA submittal in Q4 16, Approval in USA mid 2017, Vitaros only has to prove safety of the permeation enhancer DDAIP, with many world approvals and safety data on 1 million doses, this should not be a problem.
5. Recordati just launched 5 more countries, expect 5 more launches by end of Q1 2017
6. Lebanon approved, expect additional launches in Mid East
7. Rayva Ex-USA or global deal w/ current partner in EU, possible 2H 2016
8. Partner deal in China/Japan
Vitaros revenue has not grown to expected levels over the last two quarters, driven primarily by decisions made by former partners to reduce and/or suspend commercialization activities in key markets.
However, we continue to see sustained Vitaros utilization in France, Italy, and Spain, where marketing efforts have been consistent over time. And we strongly believe that through the commercial efforts of Ferring, Recordati, Majorelle, and Bracco, Vitaros can regain the sales momentum in Europe that we witnessed when Vitaros was first launched.
Recent SEEL News
- Form 8-K - Current report • Edgar (US Regulatory) • 09/03/2024 01:00:17 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 08/26/2024 04:15:16 AM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 08/20/2024 08:01:49 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 08/16/2024 08:02:17 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 08:05:46 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 08/09/2024 08:02:49 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2024 08:06:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/26/2024 08:01:17 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/16/2024 08:05:10 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/12/2024 01:15:52 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 06/14/2024 08:06:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/05/2024 08:05:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/21/2024 08:01:36 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 05/20/2024 08:16:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/16/2024 01:00:52 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/14/2024 03:45:26 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/14/2024 12:00:41 PM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 03/06/2024 10:32:04 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/06/2024 09:50:40 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/01/2024 10:39:18 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/06/2024 10:26:45 PM
FEATURED Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • 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
North Bay Resources Announces Mt. Vernon Gold Mine Bulk Sample, Sierra County, California • NBRI • Sep 11, 2024 9:15 AM
One World Products Issues Shareholder Update Letter • OWPC • Sep 11, 2024 7:27 AM
Kona Gold Beverage Inc. Reports $1.225 Million in Revenue and $133,000 Net Profit for the Quarter • KGKG • Sep 10, 2024 1:30 PM