Member Info for Titania

https://www.youtube.com/watch?v=b-S1M7MANYs

Synairgen not mentioned.

He has just been talking about Activ 6 with Dr Stites so other parts of Activ NIH program seem to still be happening.

But epidemiologist and infectious-disease specialist Peter Horby at the University of Oxford, UK, says that the studies of people in hospital might have been too small for researchers to draw a firm conclusion. It’s a common problem during the pandemic, he says: many investigators launched quick, small trials, enrolling too few participants to yield clear answers. Some treatments were abandoned prematurely. “The studies weren’t big enough, and stuff was being ditched way too early in our opinion,” he says.

The RECOVERY trial will also begin to unpick whether these antivirals work synergistically when given together. Some participants in the trial will receive one of the drugs; others might receive a combination of the two, or one of the antivirals together with a monoclonal antibody. Researchers hope that combining antivirals can boost their effectiveness and reduce the chances that the virus will develop resistance to the drugs. “We don’t have many antiviral options,” says Horby. “If we lost any, it would be a disaster.”

https://www.nature.com/articles/d41586-022-00562-0

The announcement comes ahead of the UK government hosting CEPI’s Global Pandemic Preparedness Summit on 7 to 8 March in London. The event aims to raise funds for CEPI’s goal, backed by the UK during its G7 presidency last year, to cut the time it takes to develop new vaccines to 100 days, including ‘variant-proof’ vaccines that will work against multiple
future COVID-19 variants.

https://cepi.net/news_cepi/uk-pledges-160-million-to-cepi-to-boost-global-vaccine-development/

Chipping away at the two-trial dogma
When she became CDER director in 1994 and for several years after, “we had divisions insisting on two trials for approvals of everything, including closely related indications, or even for approvals of dosage forms,” Wood**** told BioCentury. “It was like Noah's Ark, marching two by two.”

The requirements were irrational, she said, because nothing was gained by duplicating effort when “one more trial would really give you extremely robust evidence.”

In 1997-98, Wood**** and Robert Temple, acting deputy director of CDER’s Office of Drug Evaluation-I, co-authored guidance documents that chipped away at the two-trial dogma.

“We had many reviewers at the time who thought you should do the same study twice,” Wood**** told BioCentury. “What we said in the guidance is, no, if you study some other aspect of the disease and also show the drug’s effective, that's even more robust evidence and it's actually more informative than just repeating the same thing over and over again.”

The ideas are not controversial now, but “at the time these were new concepts,” Wood**** said. “It gets down to those weren’t the questions to ask, so why should we put patients through all these different trials just to check a box.”

By changing the standard so one highly persuasive, statistically significant study, or a single study together with confirmatory evidence, could support approval of a drug, “Janet Wood**** changed medicine,” Frank Sasinowski, a director at the law firm Hyman, Phelps & McNamara and a former senior FDA official, told BioCentury.

https://www.biocentury.com/article/640486/how-wood****-has-changed-fda

Posting again for those who missed this the first time around. An amazing insight!

https://www.statnews.com/2022/01/28/janet-wood****-covid-monoclonal-antibodies-pediatric-vaccines/

I'm posting again just in case anyone missed this first time around.

Sorry that reply was to TommyD_19

This is the line of reasoning that makes the most sense right now.

Might be that 13% (79 people) in phase 3 that didn't have steroids are all in the treatment arm and so 1.58 times the number of people treated with SNG001 in Phase 2. Looking forward to seeing results for those 79!

I think the answer might be in this paper!

https://www.nature.com/articles/s41598-021-85539-1

https://bmjopenrespres.bmj.com/content/8/1/e000969

Poor Covid outcomes with Idiopathic Pulmonary Fibrosis

"Pulmonary fibrosis is a feared complication of respiratory infections. We found that among survivors of severe COVID-19, 20% of non-mechanically ventilated and 72% of mechanically ventilated individuals had fibrotic-like radiographic abnormalities 4 months after hospitalisation. The presence of these radiographic abnormalities correlates with decrements in lung function, cough and frailty. Greater initial severity of illness, longer duration of mechanical ventilation and shorter blood leucocyte telomere length are independent risk factors for the development of fibrotic-like abnormalities."

https://thorax.bmj.com/content/76/12/1242

https://www.nationalhealthexecutive.com/articles/uk-pledge-ps160m-coalition-epidemic-preparedness-innovations

And building on the Five Point Plan I set out at the United Nations and the agreements reached at the UK’s G7 last year, we are working with our international partners on future pandemic preparedness, including through a new pandemic treaty, an effective early warning system or Global Pandemic Radar, and a mission to make safe and effective diagnostics, therapeutics and vaccines available within the first 100 days of a future pandemic threat being identified.

And we will be hosting a global pandemic preparedness summit next month.

https://www.gov.uk/government/speeches/pm-statement-on-living-with-covid-21-february-2022

Both Lilly and Regeneron say they have next-generation drugs in development that do hold up against Omicron, and Lilly says it’s completed Phase 2 trials and that it has hundreds of thousands of doses already made. On Twitter this week, former FDA Commissioner Dr. Scott Gottlieb called for a regulatory pathway that would authorize new antibodies quickly based on human safety data and lab evidence of effectiveness against new variants. Is that something that’s on the table under consideration here?

Certainly. In February, FDA published guidance for industry on what we would do, for example, if variants escaped diagnostic tests and how we would monitor for that. If the variants escaped vaccines, what would we do there to get additional vaccine available from the same platform, and what we do about monoclonals. And so there we talk about what companies would need to do, and it is a very streamlined program compared to what was done originally with the monoclonal antibodies.

"One of the criticisms that we’ve heard this week is that there’s no clinical data from human trials and that the laboratory data hasn’t been peer-reviewed. Do these criticisms hold any water with you or the agency?"

https://www.statnews.com/2022/01/28/janet-wood****-covid-monoclonal-antibodies-pediatric-vaccines/

"The $30 billion request includes $17.9 billion for vaccines and therapeutics, two sources familiar with it said."

https://www.reuters.com/world/us/biden-administration-seeks-30-bln-more-congress-fight-covid-19-sources-2022-02-15/

Agree Tommy. We seem to have 2 threads. Repeating post from the other thread as its a big point for those not already in the know:-

"The ACTIV-2 study team is led by protocol chair Davey Smith, MD, a translational research virologist, head of Infectious Diseases and Global Public Health at University of California San Diego School of Medicine and co-director of the San Diego Center for AIDS Research ."

For those who do not already know:-

"The ACTIV-2 study team is led by protocol chair Davey Smith, MD, a translational research virologist, head of Infectious Diseases and Global Public Health at University of California San Diego School of Medicine and co-director of the San Diego Center for AIDS Research ."