This is actually a very interesting topic. I have tried to get a copy myself years ago, and received the same reply.
The original license agreement has seen changes over the years, the most recent (that we know of) in the lead up tp the FujiFilm licence agreement (RIP) back in 2019:
Looking at the above, the last item stands out, given that it had to be extended back in 2019: milestones.
What are these milestones:
In other words: a) IND with the FDA (or an equivalent foreign agency) on or before 26 March 2017, b) file a BLA with the FDA or an equivalent foreign agency) on or before 26 March 2021, c) receive FDA approval (or an equivalent from a foreign agency) on or before 26 March 2024.
Cynata met "a" back in 2016, with MHRA approval to conduct the P1 trial received in September as a result of an IND equivalent application. With the timelines being in doubt by 2019 after years of working on the execution of the license option agreement with FF, the timelines "for certain interim development milestones" had to be extended, leaving however "c" unchanged (which seems to have changed since 2013 as it now refers to a new approval "deadline" by 2026. Question is the new "b" deadline.
Looking at our current pipeline, which indication could reach approval by 2026?
You'd think our P3 trial in knee OA, however the most recent CEO letter mentioned the following:
With a primary outcome measured "24 months post-treatment allocation (first treatment intervention dose), that would make it late 2026. Hopefully that was simply a typo (a lot of words go into such a lenghty CEO letter, as such a small mistake of mixing up "2022" and "2024" or alternatively "enrolement" and "data collection" can easily happen...) since the official trial records shows the following: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379726&isReview=true
GvHD?
Given the likely lengthy recruitment process and in addition to that still requiring a P3 trial, I would consider it very "optimitistic" (to say the least) to expect approval by end of 2026.
4 more years, unless these are "soft" deadlines and can be further extended (with the reason being COVID...).
@JB1975, this is the eurekareport @@philby is referring to: https : // www. eureka report dot com dot au /investment-news/cynata-therapeutics-limited/145444
What do you want to happen within the next 3 months to stop time from running out?
Hopefully there'll be plenty of opportunity for brainstorming in the ocean between now and then, but lets say there isn't and the things you expect to happen don't happen, what is/would be your plan? Hunger strike? Sell? Let your shares do the talking and see if other holderss shares want to do the same?
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