TLT- my jottings from the w/e Al K interview (based on a single listen so I may have missed something subtle, or not):
Korelin 2016-07-30ish weekend report at Sprott Resource event
kereport.com
00:49:20 Start
Q. ITA delayed, why?
A lot of info required, biocompat, sterilizing, mech and electrical and ? testing.
Had teams of up to 15 people working full time 7 months, finally submitted it, asked for expedited approval for Aug approval but don't know.
[So no explanation as to why delay (in relation to prev statements/claims)]
Q. If not expedited?
For ITA is 30 day clock, 4 days review, 4 days assess, 15 days to go through tech. If they ask questions the clock just continues and continues. Can take as much time as they want.
[And presumably can simply not approve it all!]
Q. (as taken from blog) Effect on financials, raise money now or later?
Blah blah, never enough capital, scientifically challenging, technically challenging, a lot of work
Company is doing fine.
1.9m cash, 300k burn with no sales. TLC-200 "is doing quite well" So ok to end Dec.
Can enrol as soon as have ITA. Site approved.
30 day follow-up on first 3 patients (Sep - mid Oct). Once we have that data then we look to raise capital, hopefully at much higher sp.
00:57:41 ends
Various positive comments were made, no disapproval of delays blah blah. |
