Map Pharma (MAPP) Hosting Call to Discuss Levadex: Doesn't Expect to Change Device Amid CRL, to Submit Request for FDA Meeting Today
- Apple, Inc. (AAPL) Tops Q2 EPS by $1.44; Announces 7-for-1 Stock Split
- Market Wrap: Big Earnings Galore; Amazon, HBO Enter Agreement; GE Eyes French Industrial Giant
- Facebook (FB) Tops Q1 EPS by 10c
- After-Hours Stock Movers 4/23: (ANGI) (AAPL) (FB) Higher; (HEAR) (TNP) (IM) Lower (more...)
- Qualcomm, Inc. (QCOM) Tops Q2 EPS by 9c; Guides Q3 to Low-Side of Consensus
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
- Prothena Corp (PRTA) to Present Update on NEOD001 Phase 1 Interim Data at XIV ISA
- Immunomedics, Inc. (IMMU) Updates on Ongoing Pipeline, Developments
- Cytokinetics, Inc. (CYTK) to Present BENEFIT-ALS Results at 66th AAN
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!