Map Pharma (MAPP) Hosting Call to Discuss Levadex: Doesn't Expect to Change Device Amid CRL, to Submit Request for FDA Meeting Today
- Futures fall on Trump's protectionist address
- Qualcomm (QCOM) Calls Apple's (AAPL) Claims 'Baseless'
- Unease over Trump sends dollar to one-and-half month low
- Kate Spade (KATE) Said to Attract Interest from Coach (COH) and Michael Kors (KORS) - Bloomberg
- European stocks hit three-week low as Trump reality sets in
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
- ADMA Biologics (ADMA) to Acquire Assets from Biotest Pharmaceuticals
- Kamada (KMDA) Announces Positive Scientific Advice Response from CHMP on G1-AAT IV for aGvHD
- Allergan (AGN) Announces FDA Approval Of RHOFADE Cream to Treat Redness Associated with Rosacea
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!