Map Pharma (MAPP) Hosting Call to Discuss Levadex: Doesn't Expect to Change Device Amid CRL, to Submit Request for FDA Meeting Today
- Market Wrap: Initial Claims Show Modest Gain; GE Bring on Q1 Beat; Wal-mart Gets into Money-Transfer Game
- Streetinsider.com After-Hours Movers 04/17: (AMD) (SCSS) Higher; (ACTG) (AVGO) (ATHN) Lower
- Advanced Micro Devices, Inc. (AMD) Tops Q1 EPS by 2c; Sees Q2 Revs +/- 3% Q/Q
- General Electric (GE) Tops Q1 EPS by 1c
- athenahealth, Inc. (ATHN) Misses Q1 EPS by 5c
Map Pharma (Nasdaq: MAPP) is currently hosting an investor call related to Levadex. Below are some highlights.
- The FDA did not request more clinical studies and instead is concerned with third-party manufacturing.
- The FDA also had questions about the usability of the inhaler.
- The Administration asked for more time to review data.
- MAP's CEO Tim Nelson said he doesn't expect any need for a change to the device.
- The company will submit a request for an FDA meeting today.
- An FDA meeting with the company may be 60-75 days away.
- Issues with the FDA have no effect on the company's contract with Allergan (NYSE: AGN).
You May Also Be Interested In
- UPDATE: Avago Tech (AVGO) Active Following Patent Case Ruling
- Spectrum Pharmaceuticals (SPPI) Appointed Joseph Turgeon as President and COO
- GT Advanced Technologies (GTAT) Will Report Q1 Results May 7th; Street Sees Wider Loss
Create E-mail Alert Related CategoriesConference Calls, Corporate News, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!