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August 9, 2013
17:48 EDTIMMYImprimis says manufacturing issues to cause delay of clinical trials
In August, Imprimis Pharmaceuticals, was notified by its manufacturing supplier, DPT Laboratories of preliminary stability test results related to clinical materials of active and placebo bulk batches of the companyís Impracor drug to be used in planned Phase 3 clinical trials, which were manufactured at DPTís San Antonio, Texas facility. The preliminary test results revealed an out of specification result for the placebo formulation and a lower than expected specification result for the active formulation. Shortly thereafter, a retest was performed, which confirmed the out of specification results for the placebo batch and revealed continued decreasing stability results related to the active batch. On August 9, the company concluded that due to the decreasing stability results for the active batch, packaging of the materials would be put on hold, as further decrease in stability levels was likely and would result in the material being unusable for the upcoming planned Impracor clinical trials. The company is evaluating its options regarding these manufacturing issues, which include re-manufacturing the clinical materials at DPTís facilities, which would result in a delay of the its planned clinical trials by 1-2 months, or moving the formulation and manufacturing process to another third party vendor, which could cause a delay of up to 6 months. The company is working with its vendors to evaluate further options related to the production of clinical materials for the Phase 3 clinical trials and the continuation of the planned Impracor Phase 3 clinical program.
News For IMMY From The Last 14 Days
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November 24, 2015
08:37 EDTIMMYImprimis and Nvision Eye Centers enter into agreement
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November 13, 2015
08:22 EDTIMMYAmerican Academy of Ophthalmology to hold annual meeting
AAO 2015 is being held in Las Vegas, Nevada on November 13-17 with webcasted presentations to begin on November 13 at 11:50 am. Webcast Link
November 12, 2015
16:16 EDTIMMYImprimis sees FY15 revenue $9M-$11M, consensus $11.97M
16:16 EDTIMMYImprimis Reports Q3 revenue (41c), two estimates (38c)
Reports Q3 revenue $2.7M, two estimates $3.42M.

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