ema feb meeting

In the notes from the ema's feb meeting there is no mention of Vitrogro.

However there is a reference to a "Prevention and treatment of infected diabetic foot ulcers" indication.

It's interesting that this is not classed as a Chemical or Biological, but as a "Other innovative".

I've no idea if they are referring to Vitrogro, but it could well be. It is flagged as "Follow-up Scientific Advice".

There definition of this is:

"Scientific advice

Scientific advice is when the Agency gives advice to a company on the appropriate tests and studies in the development of a medicine. This is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients.

Companies can request scientific advice from the European Medicines Agency at any stage of development of a medicine, whether the medicine is eligible for the centralised authorisation procedure or not.

Scientific advice helps the company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorisation application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorisation. Following the Agency’s advice increases the probability of a positive outcome.

The Agency gives scientific advice by answering questions posed by companies. The advice is given in the light of the current scientific knowledge, based on the documentation provided by the company. It is not the role of the CHMP to substitute the industry's responsibility for the development of their products.

Scientific advice is prospective in nature. It focuses on development strategies rather than pre-evaluation of data to support a marketing-authorisation application.

Scientific advice received from the Agency is not legally binding on the Agency or on the sponsor with regard to any future marketing-authorisation applications for the medicine concerned."

link:
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/02/WC500139201.pdf

Definition link:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000049.jsp&mid=WC0b01ac05800229b9