Charles Jillings, CEO of Utilico, energized by strong economic momentum across Latin America. Watch the video here.
Posted on ADVFN:
http://audioboom.com/posts/8062692-vadim-alexandre-discusses-polarean-imaging-s-new-drug-application-resubmission
Interesting explanation of risk: clinical trial/regulatory/commercial.
TommyD_19,
‘….it’s all guesswork’ correctly sums it up!
It still astonishes me that all these great brains allowed themselves to be seduced into thinking that SNG001 could take on not just placebo, as listed, but virtually ‘allcomers’.
And what makes it worse is that Parexel would have seen the patients being recruited (some already on steroids!) and still kept going to completion!
You couldn’t make it up….sadly.
:-(
TommyD_19,
Thanks.
I know this has probably been done to death, but I can’t understand why there was no mention of ‘standard of care’ in the US version:
‘Detailed Description:
Eligible patients with SARS-CoV-2 infection confirmed by a positive virus test and who are hospitalised due to COVID-19 and require oxygen therapy, will be randomised in a 1:1 ratio to receive SNG001 two syringes or placebo two syringes. SNG001 or placebo will be administered via the Ultra nebuliser. Patients will receive a dose of SNG001 or placebo once a day for 14 days and will be followed up for up to 90 days after the first dose of study medication. Study data will be collected from patients daily, as per the study schedule.’
Presumably Wilkinson’s the man behind the study design?
Just buying time, imho.
Could someone show me where the Sprinter protocol specifies patients inclusion who are already receiving standard of care.
It’s not shown here:
https://clinicaltrials.gov/ct2/show/NCT04732949
Yes, the complications of FDA submissions for a drug- device combination is discussed here:
https://www.**********.co.uk/articles/vadim-alexandre-polarean-imaging-the-chance-of-fda-approval-commercialisation-95cc21c/
Justin Waite adds little.
His talks and interviews on Youtube etc are imho most impressive and reflect his confidence in their imaging system.
I must admit it would have been interesting, to say the least, when the FDA’s CRL hit his desk….
WOWZERS!
Jourdan’s quite a fan of Polarean, hence Amati’s pretty massive holding.
No doubt the Board have had a private word - which may be behind his criticism of the FDA over their CRL - to reassure him as per the RNS.
Can’t see that unwinding his position is practicable, as the sp would collapse - even further! Imho.
‘I know it’s popular to bash RM…’
Not my objective, but as Frank Lampard showed after Everton’s recent 5-0 thrashing by Spurs, it’s expected that as the Manager, you will personally front-up and show that you’re still in the fight and ready for the next battle.
It just comes with the territory.
Just as in sport, so in business.
I’d be surprised if Richard Marsden’s had a more traumatic day than when announcing the failure of SNG001 to meet the endpoints of the phase 3 trial.
Imho, that was reflected in one of the ‘worst’ biotech RNS’s ever released - and displayed a complete lack of respect for long term investors, some of whom had unfortunately over-committed financially, based partially on the optimistic moves of the company to invest in new personnel and enlarged co. structure.
The total collapse in the share price has been accompanied by a collapse in the professional credibility of the Board and, to a lesser extent, the clinical reputation of several esteemed Professors. And yet, has anything been seen or heard directly, or even via the media from the CEO?
I’d like to feel that he’s not sitting in a darkened room with his pants on his head, a stick up each nostril , saying ‘wibble’.
Volume traded very low as usual(0.1%) so insignificant - but sufficient to move the sp down - while we wait for news on their FDA re-submission.
Perhaps forced sellers from falling investments elsewhere, as doesn’t make a lot of sense otherwise.
Let’s hope Amati hold onto their 26m.