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Spideyboy

11/30/17 4:29 PM

#8731 RE: Scott999 #8730

Hi Scott,

Thanks for the post and much appreciated, I simply try to stick to the facts.

With regards the 2018 mark I mentioned, this was a quick guess from the only thing I have to go on which is the clinicaltrals.gov page for the CLI phase III trial:

https://clinicaltrials.gov/ct2/show/NCT03006770?term=pluristem&rank=1

Here it is stipulated that anticipated end of the study for the total sample of 246 patients would be in May 2020, having started in May 2017. Hence that would be a planned 3 year study to completion. So if we need half of the patients (123) for the conditional approval, then I was quickly thinking 1.5 years, which would put us end-2018. But here I will agree that you are probably right, and thus most likely in calendar year 2019, preferably by end 1H 2019.

Six months between clinical trials doesn't seem a particularly outstanding wait to me. I have other companies which have even better clinical results and with strong partners and arguably even bigger market potential and it's taking them almost a full year now to get their Phase III going, but it's still in planning. Designing a clinical trial is a make or break binary process for an R&D company, good or dead. Planning even basic murine work takes months not to mention the ethical and legal hoops to jump through. These cost a fortune and only one chance to get it right. NHPs are a whole different ball-game. I've heard in certain circumstances it can take a year just to get approval to test on NHPs. While we do have the government backing, the process will still of course be long-winded. Trials have to be made as perfect as possible, you can't just say "ah yeah, we didn't do that one well, wish we had looked at X,Y,Z. Let's try that again". If you're big pharma for sure, billions in bank. Unfortunately that's not us. We'd be a lot more annoyed with poor trial design and results than just needing to wait.

Overall again, I'm not surprised we are where we are. Heck it's pretty obvious I'd say.