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Ampio Pharmaceuticals Inc (NYSEAMERICAN:AMPE) Update On OLE Study Of Ampion™

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Ampio Pharmaceuticals Inc (NYSEAMERICAN:AMPE) reported the start of an Open Label Extension trial of Ampion™ in patients with grave osteoarthritis of the knee. The OLE trial provides patients an opportunity to get repeat injections of Ampion™ once they have concluded the pivotal clinical study. This OLE trial will address the regulatory requirements to permit an expanded commercial label for repeat dose of Ampion™.

The details

Ampion™ marks as the low molecular weight fraction of pharma 5% HAS, which is the only starting material utilized to manufacture Ampion™. It has been administered to patients for over 60 years with a validated safety profile. Ampio uses the safety profile of HSA to advance a product for people that has the potential to meet the unmet medical requirement of severe osteoarthritis of the knee.

In unrelated news, Ampio reported the receipt of notification that the firm’s plan to get compliance with the NYSE American’s sustained listing standards has been permitted by the NYSE American LLC. As previously announced by the firm in the month of September, the firm obtained a notification from the NYSE American stating that Ampio was not in acquiescence with the continued listing guidelines of the NYSE American Company Guide pertaining to stockholders’ equity.

The notification indicated that the firm was not in compliance with different sections of the Company Guide, which need a listed firm to have stockholders’ equity of at least $4 million if it has recorded losses from continuing operations or posted net losses in 3 of its four recent fiscal years; and at least $6 million if it has recorded net losses or losses from continuing operations in its five recent fiscal years.

Ampio filed a plan to regain compliance as mentioned above and the plan has been approved by the NYSE American. The firm has been granted time until March 1, 2019, to follow its plan.


 

 

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