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: CPI Slips in Jan.; The 'Net Gets More Neutral; Apple Plans Watch Event
- Gap, Inc. (GPS) Tops Q4 EPS by 1c, FY EPS Guidance Misses
- After-Hours Stock Movers 02/26: (SREV) (BLOX) (MNST) Higher; (TUBE) (RESN) (VTAE) (WTW) Lower (more...)
- Herbalife (HLF) Tops Q4 EPS by 16c; Guides FY15 Below Views
- JCPenney (JCP) Posts Breakeven Q4 Loss; Comps Rose 4.4%
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).
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Berkshire Hathaway (BRK-A) Will Report Q4 Results on Feb. 28th
- Gilead Sciences (GILD) Issues Encouraging Update on Harvoni Phase 3 as Genotype 1, 4 HCV Treatment
- Diplomat Pharmacy (DPLO) to Acquire BioRx in $315M Deal
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!