Posted On: 09/10/2016 3:14:10 PM
Post# of 30052
If the partner turns out to be Chinese it looks like they would need to get approval from the Chinese government:
http://www.china.org.cn/english/features/inve.../36752.htm
http://www.pathtochina.com/reg_jv.htm
I asked Fred about the Ped.Disease Designation and he didn't seem to know anything about it- it definitely seemed that any delays are not related to it.
He said it was 'extraneous' items and “outside of Gerald’s control” so my best guess is that it is something regulatory/legal. Maybe the FDA re: trial design, training, the approval path etc. / Nasdaq (if they’ve even started communication with them) and/or the Chinese gov. if the partner is Chinese. I asked him how long it would take- "a couple weeks, 6 months?" His response- “I wouldn’t want to put a number on it” so who knows.
http://www.china.org.cn/english/features/inve.../36752.htm
http://www.pathtochina.com/reg_jv.htm
I asked Fred about the Ped.Disease Designation and he didn't seem to know anything about it- it definitely seemed that any delays are not related to it.
He said it was 'extraneous' items and “outside of Gerald’s control” so my best guess is that it is something regulatory/legal. Maybe the FDA re: trial design, training, the approval path etc. / Nasdaq (if they’ve even started communication with them) and/or the Chinese gov. if the partner is Chinese. I asked him how long it would take- "a couple weeks, 6 months?" His response- “I wouldn’t want to put a number on it” so who knows.
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