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In the scope of PHC14: How detailed should be the submitted budget in such a case?
Question details:
In the scope of PHC14: as the clinical development is depending on the data that will be obtained in preclinical studies, it will be difficult to have a precise budget to submit. How detailed should be the submitted budget in such a case? How detailed must be the study information that we will submit to H2020?
Answer:
For PHC 14 (rare diseases) you are advised to contact EMA very early in the process. This is: before submitting stage 2 you MUST HAVE received orphan drug designation, so start contacting EMA today! http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/gen... http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/gen...Air Max 90 Woven