@LeftYahoo "I'm not here to defend the FDA, in fact I've stated repeatedly (@DV) that I grant there may be... bureaucratic inefficiencies... "confusion"... unfairness... undue big pharma influence and the like. It's not an excuse for 2 CRL's in this setting."
That's the FDA I thought I knew. But something else seems to have risen up these past three years, which I guess I've seen coming for some time. I've mentioned here before the sugar industry paid three Harvard professors to demonise saturated fat, leaving the population deficient in fat soluble vitamins A and D. This imo has been one of the myths most damaging to general health. Early in the pandemic, I recall reading an article in the MSM referring to a study that purported to discredit vitamin D as helpful in potentially reducing the risk of severe Covid, which I view as heinous.
In this post 68523605 the first link is to a lecture by UK cardiologist Dr. Aseem Malhotra talking about his paper on the statins' RCTs which failed to show mortality benefit and (failed) attempts by scientists with vested interests to censor it on the grounds it would cause deaths if people stopped taking them. Sound familiar?
This speaks to a group (above the FDA and even pharma, which I no longer view as uniformly corrupt) who have a long-term view to cause disease and come up with the "treatments", revealing what Malhotra and Dr. Ahmad Malik and others call the "psychopathy" of the industry. I don't see why mass killing and maiming for profit should come as a surprise to anyone.
Are you familiar with an in-hospital Covid treatment protocol (used mainly in the US but I suspect here in Australia too based on my meeting with a physician in Melbourne who treated Covid patients) that some physicians and nurses have stated publicly was killing patients? Veteran RN Colette Martin's testimony was in a formal setting at the Louisiana House of Reps (link below)
(I can't find the time Colette Martin speaks in the original recording; the clip is from rumble but it's clearly the same setting in which she and two other ICU nurses - cardiac and general - give evidence against mandating the Covid vaccine for children because of the "terrifying" side effects they say they've seen which they all say are not being reported to VAERS)
The cornerstone of the protocol is the drug Remdesivir. The RCT failed to show mortality benefit (the PE was changed to suggest some sort of benefit to ensure it passed the "gold standard" for approval, although the WHO recommended against it in 2020.)
I'm surprised therefore you said this drug helps "many patients" and that you couldn't see the wider implications for Remestemcel's RCT in CARDS based on your post on 29/08/20: 46917276
"Remestemcel-L has competing medications for ICU patients, but I do not consider anti-viral meds like remdesivir, primarily used prior to intubation, to be competitors. Rather rem-L will get remdesivir's failures. Statistics show remdesivir helps many patients - but not all. Nowhere close."
Over 17000 (at that time of publication) doctors and nurses have signed a declaration (link below) alleging crimes against humanity. Dr. Malik has started a petition to end censorship in medicine.
Our company is trying to get approval for its safe medicine for children who are the most desperately unwell, who are actually patients. They've come up against a group who are obsessed with turning healthy children into patients. This is something global. I don't think we're up against the FDA.
(20min delay)