Mozz's notes from conf:
PART 2
1) Paul went on about molecule within molecule called Moiety and that the FDA are acutely aware of this and our action in regards to this.
(Mozz note: yes we will need to research the meaning of this...)
2) 2021 Aus Launch Update in terms of revenue...There was some discussion of it taking a while to get the TGA submission going as there are a number of questions that TGA have asked and PAR want to answer them correctly with a level of detail. I think it now sounds like a Q4 Submission timeframe wit possible revenue of 2021 but one of the others may have to verify this point as my audio feed was terrible during this part.
3) In terms of FA (Pre Ind) the agency gave important feedback and instructions for the progression to the next stage (NDA) so that PAR and continue to next stage...
4) There was some mention of a separate trial ongoing at the moment...also mentioned 35 patient's data has been acquired under compassionate use. I assume this is within AUS, (Mozz Notes: I believe this is still within the realm of OA and will add to the effective SAS data we have, all part of the effective submission to the FDA).
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