TO the NAYSAYERS...including MANI!17 Jun 2019 11:51
Hereith is a post i emailed to investigators last week, trying to ascertain, primarily for HER benefit, the reason of the figure of 0.08 being not statistically significant......ONCE again, as i stated - it was due to low sample.....either way, not far off 0.05.........but read and enjoy believers!...No wonder shes been quiet - iff shed had the gall to contact them herself.........which she either did not..or did and got the same response - so decided not to blab about it.....
Here it is!
Me:
"to investor.relations
Dear Sirs can you please clarify, how this study confirms previous analysis wit a p value of 0.08? Usually you would think that that is not statistically significant, especially with such a small cohort of patients? I await an urgent response.
Many thanks"
Response:- (which i received 2 minutes ago)
"to investor.relations
Dear Sirs can you please clarify, how this study confirms previous analysis wit a p value of 0.08? Usually you would think that that is not statistically significant, especially with such a small cohort of patients? I await your timely response"
Many thanks
Their reply :-
Dear Mr Xxxxxxxxx,
Many thanks for your email. We respond to queries on behalf of senior management at Faron.
While the results were not statistically significant – as you say, the patients numbers were very small – the Company believes they are consistent with the INTEREST data and support the earlier assumption that co-administration of steroids with Traumakine in patients inhibited IFN-beta action. The phase III Japanese Traumakine study, undertaken by Faron’s partner Maruishi, also supported this finding. And ex-vivo human lung studies have also shown that cortisone blocks completely INF-beta signalling pathways, an effect also seen in human primary lung endothelial cells.
As Markku Jalkanen, Faron’s Chief Executive Officer, said in Friday’s statement, the YODA report will now be used in discussions with regulators on the design and next steps for a further phase III trial of Traumakine in the treatment of ARDS.
Best wishes.
David Daley
Senior Associate Partner"
(from Consillium)
Im happy with that response - Onwards and upwards!