Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-175

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04/05/22

04:55

Post #: 61185194
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Originally posted by whytee: ↑

"An additional trial in children for GVHD is unethical and would not be feasible in any jursidiction, the ODAC panel said it in their transcript which is why they voted on balance 9-1 in support of approval?

I'm certain that the ODAC panel as a panel didn't say that. "

Yes, the ODAC panel didn't say that. But Silviu Itescu DID say that, quite recently in fact, in a webcast interview. So its not surprising that investors get confused. And its not surprising that the company got sued for misleading investors.

But here's the thing. It wasn't considered "unethical to conduct the two aGVHD randomised controlled clinical trials previously and given that they both failed to achieve the primary end points there is even more reason to doubt the efficacy of the treatment. What we end up with is SI claiming that the new production process has lead to an improvement in the product that results in better "activity". Yet there is no well conducted clinical trial to show that is actually so, except some "expert opinion" that SI claims makes conducting a further trial "unethical".

Given the failure of the previous two trials and the fact that "expert opinion" constitutes the lowest grade of scientific evidence it is perfectly ethical to conduct such a trial until such time as there is higher quality evidence of efficacy. In fact it is essential that a proper trial is done to conclusively show whether or not it works and how well it works and appropriate dosing so that those who will benefit can receive proper treatment and to avoid wasting precious resources if it doesn't. And it would no doubt help in elucidating a mechanism of action which MSB reminds us "remains theoretical".

I accept the fact that investors in the company and MSB will vehemently oppose such a trial and insist that it works because of the intense financial motivation, and to avoid the potentially disastrous consequences of another failed trial. But science is about challenging dogma and finding out truth.

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'some "expert opinion" that SI claims'

The experts here claim it, so it must be true, or is that what old mate @Pledge would call a HC fact?

Just something else mums/dads/newbies need to be cognizant of.

Just sayin'.

MSB Price at posting: $1.06 Sentiment: None Disclosure: Not Held
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