A detailed, informative presentation, as per usual. PR loves his detail.
I asked a question in relation to the TGA provisional approval and specifically about generating revenue in Australia and the timelines. Was it fair to assume that PAR wont have a chance of generating income in Q3 as previously announced.
Paul's response was basically 'Yes it's fair to assume that.' They will be presenting to the TGA for stage 2 in Q4 now, not Q3.
Takeaways:
- Each presentation to the TGA is a knockout event so they must get it right or start the process from the beginning. 1 shot!
- Whatever happened at stage 1 was positive but I suspect they took from the meeting to bring the whole kitchen not just the sink to stage 2.
- I think with the 35 patients using the same Zilosul product that Phase 3 trials will be using this data will help
- The 100-200 patient data that they'll have by Q4 will also help.
- The 100's of continuing patient data that is accruing as we speak from the TGA SAS will also add to the strength of the application
- They will also have further guidance from the EMA and FDA to also assist with the app
- If they present in Oct, we may hear something back by Dec. I am going to run on the assumption that there will not be any income generated this year. That is my assumption only.
My sentiment is a BUY, but I'm waiting for the next drop below $1.35. I believe we have plenty of time to accumulate these.
All my opinions, no advice whatsoever because I haven't a clue what I'm doing. Seek a professional.
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