Well gee that’s a bit of a kick in the nuts.
So the TGA referred it to the Advisory Committee for Medicines and they said bugger off. So like any investor who likes to do their own research, one asks who the fck are these clowns? Well it turns out that these clowns are very heavy duty medical and clinical scientists. Well that’s a bummer….
Now as it turns out the TGA doesn’t have to follow the advice of this esteemed group of scientists…
The advice provided by the ACM is an important element in the undertaking of the regulatory functions of the TGA. However, it forms only part of the information that is available to a TGA delegate making a regulatory decision under the Therapeutic Goods Act 1989. While appropriate consideration will be given to such advice, it is important to note that neither a TGA delegate nor the TGA is obliged to seek this advice in making a decision or to follow it.
(https://www.tga.gov.au/acm-meeting-statements)
But they will because they don’t want the liability if something backfires down the track. In fact, I betchya that the TGA referred it directly to these guys because they didn’t want to knock it back them selves and look like the bad guys – given its aimed at saving kids lives and the like.
So that begs the question why doesn’t anyone want to approve this life saving drug for poor starving kids in Africa?
Simplez… because the Phase III trails, as completed, were a scientific clusterf*ck and scientifically wasn’t worth the paper that it was written.
Remember that the whole thing was run by the crooks from London Pharma (and Boolsey mainly) and LP was soon to be taken over by the questionable character Frank Timis. EMS paid them and they supposedly managed it on our behalf. Sh!t it wouldn’t surprise me if the entire dataset was fabricated from the local pub in Boosley’s home town.
So how do I know all this, well obviously I don’t know Jack S.
But remember some time ago the WHO recommended that another Phase III trial was required for the pre-referral environment well that was the polite way of saying that your first PhIII trail was a piece of crap.
Anyway, we’ll know soon enough because in the name of good government transparency, the TGA has to publish the data as to why or why not the approval went ahead. So in mid-May when the final letter from TGA is received they’ll publish something here and then we’ll all know for sure.
(
https://www.tga.gov.au/australian-public-assessment-reports-prescription-medicines-auspars)
So realistically I struggle to find a reason why this is all Carter’s fault (
because everything usually is)
but he did inherit it from Dermy.
But Carter if you were any type of an honourable man and not a UWA arts student prepared to sell his mother to retain your overly generous salary then there’s a couple of things you should change in your business repertoire.
Firstly, stop blaming everyone and man the fck up. If it’s not the Ebola virus, it’s the GFC. If its not that it’s Brexit or the dodgey kraut lawyers that gave you the really bad advice about the material interest for SUD in the Berlin Pharma fiasco. Now it’s the dodgey TGA advisors who couldn’t read a piece of science if it smacked them in the face and you believed their crap. Due diligence is what you are paid for and you aren’t doing any!
Also, releasing the announcement with 3 minutes of market time before a long weekend. I bet that this was received some time ago and you were sitting on it and waiting for the long weekend.
Maybe ASIC should ask the question because the timing is suspicious and once again this is a failure to disclose relevant information. Remember last time that happen you become ASIC’s inaugural fine!!
FFS
(20min delay)