![](http://investorshub.advfn.com/images/default_ih_profile2_4848.jpg?cb=0)
Wednesday, October 19, 2011 9:57:10 AM
The $36 million company develops CPI-300, a high-strength Bupropion Hydrocloride (HCL), the active ingredient in Wellbutrin XL, which is already FDA approved in 150, 300 and 450 mg doses. Valeant (VRX), maker of Wellbutrin XL, failed to produce a single 450 mg dosage, thus allowing CPI-300 to enter the market, which is estimated to be $150 million for high dosage patients. FDA approval date is set on November 13. Marketing is expected immediately on approval. Any deal is expected to include a seven-figure upfront payment, double-digit royalties, and sales milestones.
CPI-300 employs the company’s VersaTab multi-layered technology, which is superior over single-layered drugs like Wellbutrin XL® in the sense that release-time is spread out.
Further, manufacturing is cost-effective, allowing CPI-300 to be price competitive. Patent protection extends to 2027.
The company received a complete response letter on February 8, 2010 saying that the company needs to address commercial manufacturing and food affects before approval. Since then, it has hired a manufacturer and believes a label adjustment and a post approval education can satisfy the food impact, which was observed in both CPI-300 and the reference (Wellbutrin).
Insider ownership is 46.8%, of which the CEO and his wife hold 11 million shares, or 24.27% of the company. BluMont Capital holds 11.33% and Alpha North Asset Management holds 9.99%. The three parties, considering the CEO and his wife as one party, are betting a lot on this company. Why? Do they have good chance of getting approval? The stock looks very bullish with several buy signals.
Snippet from this article:
http://seekingalpha.com/article/283655-rapidly-rising-biotech-pharmaceutical-companies-with-big-potential
Drug has already been pre-approved
FDA Decision Date: November 13, 2011
Drug to be approved: CPI-300
Market Potential: $300 million a year
Buy IGXT now!!!!!!!!
Recent IGXT News
- Form 8-K - Current report • Edgar (US Regulatory) • 06/07/2024 08:00:19 PM
- Form 1-A-W - Withdrawal of offering statement [Regulation A] • Edgar (US Regulatory) • 05/24/2024 07:49:22 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/21/2024 12:00:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 08:16:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/08/2024 08:00:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/20/2024 10:25:33 PM
- Form 253G2 - • Edgar (US Regulatory) • 02/20/2024 07:07:33 PM
- Form QUALIF - Notice of Qualification [Regulation A] • Edgar (US Regulatory) • 02/20/2024 05:15:08 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/14/2024 10:22:23 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/31/2024 09:12:29 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/31/2024 09:12:09 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/31/2024 08:58:47 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/31/2024 08:56:54 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/31/2024 08:56:39 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/31/2024 08:55:01 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/31/2024 08:52:41 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/31/2024 08:51:32 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/31/2024 08:50:21 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/31/2024 08:48:53 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 12/11/2023 09:16:43 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/04/2023 01:26:48 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/28/2023 09:18:42 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/09/2023 09:10:11 PM
FEATURED Fifty 1 Labs, Inc. Announces Major Strategic Advancements and Shareholder Updates • Jun 14, 2024 2:07 AM
ECGI Holdings Announces LOI to Acquire Pacific Saddlery to Capitalize on $12.72 Billion Market Potential • ECGI • Jun 13, 2024 9:50 AM
Snakes & Lattes Opens Pop-Up Location at The Wellington Market in Toronto: A New Destination for Fun and Games - Thanks 'The Well', PepsiCo, Indie Pale House & All Sponsors & Partners for Their Commitment & Assistance Throughout The Process • FUNN • Jun 13, 2024 8:18 AM
HealthLynked Introduces Innovative Online Medical Record Request Form Using DocuSign • HLYK • Jun 12, 2024 8:00 AM
Ubiquitech Software Corp (OTC:UBQU) Posts $624,585 Quarterly Revenue - Largest Quarter Since 2018 • UBQU • Jun 11, 2024 10:13 AM
Element79 Gold Corp Files for OTCQB Uplisting, Provides Financial Update • ELEM • Jun 11, 2024 9:25 AM