- Forum actieveling
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Jep, zit aan de champagne na de laatste 2 dagen met ACPH en EVOKKzentekik schreef:2019 zal je bedoelen...rouches schreef:26/07/2016 zullen we het weten
- Forum verkenner
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- Lid geworden op: 21 sep 2012 21:24
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SOLANA BEACH, Calif., Aug. 08, 2019 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that following receipt of U.S. Food and Drug Administration (FDA) minutes from a type A meeting held on July 25, 2019, the Company intends to resubmit its New Drug Application (NDA) for Gimoti™ in the fourth quarter of 2019. The Company also announced its financial results for the second quarter ended June 30, 2019.
The purpose of the type A meeting was to obtain the Agency’s feedback and agreement on the Company’s plan to address deficiencies cited in the April 2019 Complete Response Letter (CRL) in support of a resubmission of the Gimoti NDA. The focus of the discussion was on topics noted in the CRL, including the root cause analysis of low drug exposure in the comparative bioavailability study and additional product quality/device quality control testing.
Based on FDA feedback and the meeting minutes, the Company will include its root cause analysis and previously collected patient use and experience information in its resubmission package. The Company also agreed to provide an analysis of pump performance characteristics of the nasal spray devices used in the comparative bioavailability study and 3-month stability data from commercial scale batches of Gimoti which the Company initiated manufacturing in June 2019. FDA did not request additional human clinical trials be completed for resubmission.
“We are very pleased with the outcome of our meeting with FDA and appreciate their thoughtful approach in considering the totality of the data from our previously submitted NDA, along with a root cause analysis summary and additional quality data that will be referenced in our planned resubmission,” said David A. Gonyer, R.Ph., President and CEO of Evoke Pharma, Inc. “We now have the clarity required to resubmit our Gimoti NDA in the fourth quarter of 2019, and we believe we have sufficient funds to support our operations into the second quarter of 2020.”
Second Quarter 2019 Financial Review
For the second quarter of 2019, net loss was approximately $2.1 million, or $0.09 per share, compared to a net loss of approximately $2.3 million, or $0.14 per share for the second quarter of 2018.
Research and development expenses totaled approximately $1.2 million for the second quarter of 2019, compared to approximately $1.4 million for the second quarter of 2018. Research and development expenses were primarily related to responding to requests for additional information from FDA and manufacturing registration batches of Gimoti.
For the second quarter of 2019, general and administrative expenses were approximately $0.9 million compared to approximately $0.9 million for the second quarter of 2018.
Total operating expenses for the second quarter of 2019 were approximately $2.1 million, compared to total operating expenses of approximately $2.3 million for the second quarter of 2018.
As of June 30, 2019, the Company’s cash and cash equivalents were approximately $7.4 million.
About Evoke Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing Gimoti, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Metoclopramide is currently available only in oral and injectable formulations and is the only drug currently approved in the United States to treat gastroparesis. Visit http://www.EvokePharma.com for more information.
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