Approval process in Europe

[Fishermangents]

These documents provides a nice overview on the approval process in Europe (incl. timelines):
http://www.ema.europa.eu/docs/en_GB/doc ... 004235.pdf
http://www.georgeinstitute.org/sites/de ... oducts.pdf

[huntingonthebluffs]

Thanks for the links Fishermangents, interesting details on the lengthy process. While most, including myself, don’t understand what activities and steps are occurring during the 210 days of review or the 120 if a negative decision is appealed, it helps understand that a marketing application is not going to receive approval for many months once submitted following the phase III CT.

My question would be without receiving other designations previous to the NDA, such as ODD, BTD, FTD, PR, etc. which you referenced in the links below, we are looking at years to approval. So in your opinion, is there any process where those concerned / affected by these diseases and lack or very expensive and complicated access, if any, to Imetelstat treatments, can add their input to the equation on the need for urgency on all levels?

http://www.fda.gov/forpatients/approval ... 041766.htm

http://www.ema.europa.eu/ema/index.jsp? ... 058004d5c1

http://www.ema.europa.eu/docs/en_GB/doc ... 190556.pdf

[Fishermangents]

Hi Hunt: I wish I knew. There is a European process based on the principle of Compassionate Use. There is a process for that, although I don't if that is for individual patients. I briefly looked at it and it seems rather bureaucratic.
We will not know when JnJ will submit the NDA for imetelstat until they do it. And they can do it at any moment as soon they are confident that there are sufficient data for the authorities to base a positive decision on.

Some links about compassionate use:
http://www.ema.europa.eu/ema/index.jsp? ... 000293.jsp
http://www.ema.europa.eu/docs/en_GB/doc ... 004075.pdf