Hi Saud, Pluristem may have little control over the ARS trial, but they do have a certain degree of control over how information is communicated to the shareholder. I cannot understand this delay and it does not make sense to me either. I also do not understand what is going on in Japan.
This is a quote from the latest financial statement:
"In December 2015, we reached an agreement with Japan’s Pharmaceuticals and Medical Devices Agency on the design of the final trial needed to apply for conditional approval of PLX-PAD cells in the treatment of CLI. The approval of the protocol for the 75-patient trial was part of a larger agreement on the development of PLX-PAD via Japan’s new accelerated regulatory pathway for regenerative medicine [my emphasis].
On the one hand Japan offers a new accelerated regulatory pathway for therapies such as Pluristem's and on the other hand as far as I understand it, no trial seems to be currently happening. This does not make sense to me.
It pains me to say this, but there appears to have been a certain lack of transparency in the way certain things have been communicated and I do not like it. This is obviously my personal view and others may feel differently.
Regards,
HB
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