IMM 3.57% 29.0¢ immutep limited

Ann: Immutep receives EMA scientific advice for Phase 3 in MBC, page-19

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  1. 5,328 Posts.
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    While a possibility, my short answer is No! It is highly improbable we get "commercialisation-for-clinical use" green tick, which is in the hands of the gods to be, EMA/FDA. Good AIPAC data will help our fast track status and not need to go through comprehensive hoops with NDA (new drug application) and it may create a possibility of "provisional approval" (for commercial use) from FDA BUT REGARDLESS, clinical trials will still need to be completed, if anything, the company will be "under watch" and provisional approval will be cancelled if clinical trials are not completed. In saying that, depending on a number of factors; type of disease, how un-met it is, how good the drug is, etc, there are considerations as part of fast tracking and provisional approval to reduce the size of the phase (e.g., phase III in this case and potentially future Ph II in our other trials). All of this means about 2 years faster in commercialisation ...

    You can hopefully see, we cannot fund phase III by way of commercialisation for our first cab off the rank, Efti.

    in saying all that, mate, I can tell you, if we get good data with AIPAC & TACTI alone, not to mention other our trials, we will not have to worry about funding ... IF ANYTHING, I WOULD LOVE for shareholders to fund it as part of a SPP for example ... it will GIVE US, AND NOT PREDATORS, THE OPPORTUNITY TO HAVE A SLICE OF A GREAT COMPANY.

    But we need data, and we need to wait on that ... it is coming, hopefully good, as we anticipate and as indications are, specially with today's news.
 
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