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Monday, October 23, 2017

2 results for 'conditional marketing authorisation'

TK submission for Conditional Approval validated by EMA

By Molmed, published on Apr 1, 2014

...ever performed. Claudio Bordignon, CEO and president of the Board, will give a presentation on the topic next Tuesday 1st of April during the plenary session of the 40th annual meeting of the EMBT, which will be held in Milan from March 30th to April 2nd.

Conditional Marketing Authorisation The Conditional Marketing Authorisation represents an expedite path for early market authorisation ahead of completion of the pivotal registration studies. Such anticipated authorisation is mainly based on efficacy and safety evidences accumulated in early studies. A Conditional... (more)

Tags: molmed, tk, molmed tk, conditional marketing authorisation

MolMed TK therapy submitted for Conditional Marketing Author

By Molmed, published on Mar 16, 2014

...lack a fully compatible donor: TK offers to these patients the option of transplantation from a mismatched donor without post-transplant immunosuppression. If approved, TK would be the first cell-gene therapy product on the market for this life threatening condition. The Conditional Marketing Authorisation application is supported by cumulative efficacy and safety results obtained from a completed Phase I-II, multicentre trial (TK007). These data were included in presentations given at the 49th annual congress of the American Society of Clinical Oncology (ASCO) and at the 55th... (more)

Tags: molmed, tk, conditional marketing authorisation

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