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Subsequent Events
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3 Months Ended | |
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Mar. 31, 2015
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| Subsequent Events [Text Block] |
14. Subsequent Events
On May 4, 2015 the Company received comments from the U.S. Food & Drug Administration (“FDA”) in response to questions submitted by the Company ahead of a Type B meeting scheduled for May 5, 2015. The FDA provided guidance that if the planned Phase 3 trial of EGP-437 in anterior uveitis meets non-inferiority criteria, data from this trial along with data from a previously completed Phase 3 trial in anterior uveitis will be sufficient to support a New Drug Application (“NDA”) filing. The FDA also communicated that the design of the planned Phase 3 is acceptable and that the nonclinical work completed to date is sufficient to support a NDA filing. Based on this positive feedback, the Company elected to cancel the face-to-face portion of the meeting. |
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- Definition
The entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business. No definition available.
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