Map Pharma (MAPP) Hosting Call to Discuss Levadex: Doesn't Expect to Change Device Amid CRL, to Submit Request for FDA Meeting Today
- Advanced Micro Devices (AMD) Cuts Q2 Outlook
- After-Hours Stock Movers 07/06: (SUNE) (AAP) (CTCT) Higher; (AMD) (SHLM) (ETRM) Lower (more...)
- Deutsche Bank Downgrades Tesla Motors (TSLA) to Hold on Valuation
- Nike (NKE) to Become Wolverines' Official Athletic Footwear, Apparel and Equipment Provider
- Market Wrap: Markets Weak on Greece, China; Aetna Moves to Acquire Humana; ISM Service Index Gained in June
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
- Prima BioMed Ltd (PBMD) Receives Positive Scientific Advice from EMA for IMP321 in Metastatic Breast Cancer
- Enzo Biochem (ENZ), Luminex (LMNX) Enter Patent Infringement Settlement
- Crescent Point Energy (CPG) to Acquire Coral Hill Energy; Revises FY15 Outlook Higher
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!