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The pharmaceutical company Oasmia Pharmaceutical is not aware of its application for Apealea today.
The process will be postponed and the request will be raised at the meeting in September or October. He says the press service of EMA at Finwire. The company requested market approval for the drug candidate in February 2016. The process was delayed several times when the CHMP requested additional information on the drug candidate. Apealea is a new formulation of the paclitaxel chemotherapy drug developed for the treatment of ovarian cancer and has already been approved in Russia and Kazakhstan. At the same time, the company is working on the registration of Apealea for the US market and will also apply for registration in multiple markets.
The stock is free and is around 33% at 14:30.
The pharmaceutical company confirms that no statement has been submitted to Apealea this month, contrary to what was stated in the preliminary agenda of the month meeting of the EEA Scientific Committee, CHMP. This according to a press release.
The company also states that no oral presentation was required and that the CHMP instead proposed to respond in writing to the other questions within the time limit provided by the standard procedure. Oasmia intends to answer these remaining questions by August 21, 2018.
Di has already written about Oasmia, which has risen sharply this week while waiting for a message from him. EMA
"We are positive after this message, but of course it would have been better if we received a positive message at the moment, but we respect the actions of the authority.This is not negative or aggravating other than temporal.If this had been negative, the application would not have occurred.Therefore, I consider this to be positive, "he commented on the EMA.
New cases or complications have not been added to current demand, according to Julian Aleksov. The remaining questions are answered in writing in the calendar for the standard procedure.
"This is not new," says Julian Aleksov, while he does not want to answer the questions:
"This is the application at the level of detail.
Oasmia intends to answer the remaining questions by August 21, writes the company in a press release
"There should be no problem answering these questions until then "The grand owner, 19659007] The Oasmias share the rage of more than 30% on the Stockholm Stock Exchange Friday afternoon, so it is about the same level as last Friday after a sharp rise during the trading week close.On Monday, it was learned that Oasmia and Apealea were on the agenda before the meeting of the week, and the results of these meetings are usually published on Fridays.
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