Followers | 2775 |
Posts | 77901 |
Boards Moderated | 1 |
Alias Born | 05/10/2007 |
Friday, May 05, 2017 6:39:07 PM
The FDA wants some changes at the biotech's manufacturing plant.
Brian Orelli (TMFBiologyFool) May 5, 2017 at 4:56PM
What happened
Ocular Therapeutix (NASDAQ:OCUL) is down 15% at 3:43 p.m. EDT after the company disclosed that the U.S. Food and Drug Administration had found issues at the company's manufacturing plant.
So what
The biotech is expecting the FDA to make a decision on the marketing application for its eye-pain medication Dextenza on or before July 19, but the agency won't approve the drug -- even if it thinks the clinical data justifies it -- until the issues are resolved.
At the end of the inspection this week, the FDA inspector issued what's called a Form 483, listing what the company has to do to fix the problems. A vast majority of FDA inspections result in a Form 483 -- the reviewers wouldn't be doing their job if they didn't find something that could be done better -- so getting one isn't a big deal; the only question is how long it'll take to resolve the issues.
Closeup of an eye
IMAGE SOURCE: GETTY IMAGES.
Ocular Therapeutix said it plans to respond to the issues within 15 days with its corrective action plans. On the conference call, management indicated that they didn't think the plant would need to be reinspected, and the Form 483 issues could be resolved by July 19.
Now what
While it doesn't sound like this is a major issue, investors are justified in assigning Ocular Therapeutix a lower valuation because the issue brings uncertainty.
The inspection of its plant this week was a reinspection to resolve a Form 483 from a prior FDA inspection. Those issues were resolved through this week's inspection, which should give investors confidence that the company knows how to deal with Form 483 issues.
Investors willing to take on the extra risk could be getting a deal at today's knocked-down price.
Recent OCUL News
- Ocular Therapeutix™ to Present at Two Upcoming Investor Conferences • GlobeNewswire Inc. • 05/06/2024 11:30:00 AM
- Ocular Therapeutix™ To Present at Two Ophthalmology Meetings, May 4-9, 2024 • GlobeNewswire Inc. • 05/03/2024 11:30:00 AM
- Ocular Therapeutix™ to Host Investor Day in New York City on Thursday, June 13, 2024 • GlobeNewswire Inc. • 05/01/2024 11:30:00 AM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 03/11/2024 08:23:22 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/11/2024 08:12:44 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/11/2024 08:10:50 PM
- U.S. Index Futures Dip Ahead of Inflation Data and Oracle’s Earnings; Oil Prices Edge Higher • IH Market News • 03/11/2024 10:39:47 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/27/2024 09:43:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/27/2024 01:07:55 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/27/2024 01:06:32 AM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 02/27/2024 01:04:11 AM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 02/27/2024 01:02:45 AM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 02/22/2024 01:00:28 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/22/2024 12:34:53 PM
- AffaMed Therapeutics Announces New Drug Application Acceptance by Singapore Health Sciences Authority (HSA) for DEXTENZA® for Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery, and Ocular Itching Associated with Allergic Conjunctiviti • PR Newswire (US) • 02/19/2024 02:00:00 PM
- Ocular Therapeutix™ Appoints Steve Meyers to Chief Commercial Officer • GlobeNewswire Inc. • 02/15/2024 01:00:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/15/2024 12:48:57 AM
- Ocular Therapeutix™ Announces First Subjects Screened in Phase 3 Pivotal Clinical Trial of AXPAXLI™ in Wet AMD • GlobeNewswire Inc. • 02/13/2024 12:37:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/06/2024 11:38:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/06/2024 11:35:58 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/06/2024 11:32:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/06/2024 11:29:51 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/06/2024 11:26:40 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 02/05/2024 09:41:52 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 02/05/2024 09:39:23 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM