Ann: Quarterly Update and Appendix 4C - quarterly, page-27

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Timmmy

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01/02/22

12:21

Post #: 59271127
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Originally posted by Mozzarc: ↑

Hi Timmmy,

Ok clarification here, the Q3 22 results are only for 008 top line. (I'm assuming this is what you are referring to as you mentioned US trial enrolment finishes Q1 22. This is actually just the 008 program, don't forget to add 12 months for the extension [durability] of this program , some time to compile data and then data read out). The next step here in this pivotal subprogram would be then sitting with the FDA and preparing a larger study (maybe around 250 to 300 patients) to be able to potentially add this component (DMOAD) to the all important label once 003 is done.

Dosing for the 002 and then actual 002 and 003 will take at least 2 years, though there is a slight possibility if the data is superb there could be a faster pathway granted to eventual registration/sales etc...but it may only be a small chance.

So to answer your question, in only my opinion, there are specific points of release for top line data in these programs, we are a few years off meaningful revenue in the OA indication, with or without a partner. (Partnering wont necessarily speed anything up, though perhaps indirectly by being able to fund a few more clinical sites/staff which may speed it up a bit...?).

According to the above we are possibly looking at 2025 for NDA...and then maybe 6 months after that if it is Fast Tracked before the real revenue proposition starts in the OA program.

Again, the above timetables do have a pinch of conservatism in them so it may be slightly quicker, but why not have this end 2025 target in mind and then be pleasantly surprised if we manage to get some UPOD?

My views

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Thank you so much Mozzarc

PAR Price at posting: $1.48 Sentiment: Hold Disclosure: Held
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Ann: Quarterly Update and Appendix 4C - quarterly, page-27

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Ann: Quarterly Update and Appendix 4C - quarterly, page-27

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