Thanks for the links @ahjay. Of most significant note in there is Parallel Scientific Advice (PSA) between EMA (Europe) and FDA (USA)
https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance#parallel-scientific-advice-with-the-united-states-section
As this is explicitly and directly relevant to Immutep's trials and drug/product development, almost certainly (IMO) the application has been made.
Of particular interest therein is a joint publication (link bellow) between FDA and EMA on 15 Sep 2021 (last month!):
https://www.ema.europa.eu/documents/regulatory-procedural-guideline/pilot-programme-european-medicines-agency-food-drug-administration-parallel-scientific-advice-hybrid/complex-generic-products-general-principles_en.pdf
.... all of which may translate to significant time and money savings for Immutep from here on, given AIPAC data is good - and it only needs to be good, even "just good" (i.e. STATISTICALLY significant, not a miracle overnight cure for all diseases and ailments) and to a someone who understands the field, e.g. Pharma, FDA, EMA, Scientific and medical community and biotec and of course informed (long term) investors (like most of us here) ... but not to a short-term wannabe overnight millionaire investor, who usually expect nothing short of a miracle in each announcement!!!!!
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- Ann: Immutep receives EMA scientific advice for Phase 3 in MBC
Ann: Immutep receives EMA scientific advice for Phase 3 in MBC, page-25
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