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Just a snippet from last CRL , 6th October 2021
“ These issues are mostly technical or manufacturing-related in nature and centre around the Xenon hyperpolariser system” The FDA knew the defects then ,so now we have another 90 days on requiring further data,makes you think who playing silly buggers.
Over to Linde to provide that data , wait for January timeline [given Xmas time]in the way.
Glah
PJ
https://www.**********.co.uk/articles/vadim-alexandre-talks-about-polarean-s-new-drug-application-update-2daf57d
Sorry try this one
PJ
Update message from Vadim Alexander on vox market , check it out, a positive angle to what we are waiting for .
Glah
PJ
/>https://www.**********.co.uk/articles/vadim-alexandre-talks-about-polarean-s-new-drug-application-update-2daf57d
IMO , the FDA are slow walking it’s decision making, asking for more detail on xenon gas make up , according to the last CRL,there no mention of xenon problems , after all , there are several major hospitals including one in Oxford trialling this medical device. We must comply with FDA but again I feel POLX are harshly treated, providing all data and the kitchen sink ,to prove it’s reliability, the very best of luck to RH and his team.on Friday.
PJ
Pound \ dollar = ÂŁ1:00 = 1.09
Dollar \ pound = 1:00 = ÂŁ 0.92p
All my stocks blown into red zone , how long ? Who knows
Fingers crossed 30TH September, we will be ok , news about the xenon has should be granted , after all RH and Co have kept communications with FDA since the CRL back last year 6th October
GLAH
PJ
Hi all , this is encouraging news indeed, going forward let’s hope funding is made available but let’s not forget about the research into COPD which is what SNG started with .
Mani and Ghia , I respect both your insights into this difficult journey and before Feb 2022 we were all singing from the hymn sheet , so please let’s not get at each other let’s savour the news and if so prepare to wait until 2023 if not before for what we all wan
In the USA there are about 13,000 hospitals ,not all may not have MI R scanners but as an example as JW(vox markets)said taking only 10% ,POLX will be a multi billion company,not sure of the time line but given the green light I hope the reps
have their foot on the pedal and get the party started.
GLAH
PJ
Just how long do we think this will start commercialisation after aproval and I would be grateful for that alone.
Polx are in a good position to finance the start. I feel this could be stalled.
But the wider picture , the USA are in a recession, their NIH is probably holding back financially because of funding /or income,so therefore the orders might not come so quickly, this I see all over the world, In time yes, orders will come as the world economies recover IMO , what do think!