Map Pharma (MAPP) Hosting Call to Discuss Levadex: Doesn't Expect to Change Device Amid CRL, to Submit Request for FDA Meeting Today
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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).
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