I don't know about any eINDs issued.
They could have easily provided a grant of single or double digit millions in order to accelerate our trials on the basis of a plurality of outstanding eIND results -- but they didn't. Why is that?
If they demand P3 for M/M because the results are really good but the N= value is too small, and they don't provide any funding assistance or resources to fast track it -- it is game over.
One could almost make the same argument about not helping the S/C trial to get to 50% (195) as fast as possible, on the assumption and basis of having provided excellent M/M results -- although the DSMC is independent of the FDA.
Assuming you are stuck behind a NYT paywall:
https://www.nytimes.com/2020/07/09/health/reg...odies.html
Yes, with the notable exception of CytoDyn.Quote:The government is throwing money at everyone that might have a preventative treatment
They could have easily provided a grant of single or double digit millions in order to accelerate our trials on the basis of a plurality of outstanding eIND results -- but they didn't. Why is that?
If they demand P3 for M/M because the results are really good but the N= value is too small, and they don't provide any funding assistance or resources to fast track it -- it is game over.
One could almost make the same argument about not helping the S/C trial to get to 50% (195) as fast as possible, on the assumption and basis of having provided excellent M/M results -- although the DSMC is independent of the FDA.
Assuming you are stuck behind a NYT paywall:
https://www.nytimes.com/2020/07/09/health/reg...odies.html
Quote:Regeneron has built its business on what Dr. Schleifer, one of the company’s founders, calls its “magical mice” — animals that have been genetically engineered to have human immune systems. The mice are infected with harmless viruses that trigger the animals to produce human antibodies. Those antibodies can then be screened for the ones that work best, and then mass-produced in stainless steel vats known as bioreactors.
The technology drove one of the company’s biggest blockbusters, the eczema drug Dupixent, as well as the treatment for Ebola.
Dr. Schleifer said he realized the company would need to turn its full attention to developing a treatment in late January, when a news program showed construction vehicles breaking ground on a vast hospital in Wuhan.
“They said they were going to build a hospital in five days,” he recalled. “I said to myself, ‘Holy cow, OK, this doesn’t happen just for the fun of it.’”
In early February, Regeneron expanded a collaboration with the federal government to begin working on the coronavirus treatment. It also started ramping up manufacturing of the antibodies.
Usually, “you don’t scale it up until you’ve got something that’s proven,” Dr. Schleifer said. “We knew that the ordinary course of business could not work here. We knew that we needed to get as much capacity as possible.”
Dr. Schleifer said the company decided to move its existing products to its plant in Ireland to ensure that the antibody treatment would be made in the United States and available to treat Americans. The pandemic has already led some countries, such as India, to limit exports of drugs that might treat Covid-19, and the United States has snapped up the global supply of another treatment, remdesivir.
“There was scary stuff going on in the world about, you know, countries closing borders,” he said. “We wanted to manufacture as much as we could as close to where the processes were being developed.”
The company started its work by collecting as many coronavirus antibodies as possible, both through infecting its magic mice, and from the donated blood of coronavirus survivors.
Those antibodies were handed off to Ms. Giordano’s team, which identified the ones that fought off the virus most powerfully.
Ms. Giordano’s role was to help develop a phony coronavirus to test against the company’s antibody candidates — one that, though not harmful, would stand in for the real thing. “It was like three years of work in — I want to say — maybe like a month and a half,” she said.
By the end of February, she was clocking 90 hours a week. In March, as the coronavirus arrived in Westchester, she moved to the Airbnb apartment in White Plains — the owners gave her a significant discount when she explained what she was working on.
Ms. Giordano was listed as an author on two articles in the journal Science describing how Regeneron’s researchers had selected the antibody cocktail, including their reasoning that, by using two antibodies, they could help prevent resistance to the treatment.
In April, the scientists selected their lead candidates for the two-antibody cocktail that would eventually enter clinical trials.
Now, like everyone else, Ms. Giordano is waiting to see if the antibody treatment will succeed in clinical trials.
While antibody treatments have shown promise in the past, “the real question is how well will they work for Covid?” said Angela Rasmussen, a virologist at Columbia University. “And that’s something that’s really hard to say, because we’ve only known about this virus for seven months.”
The clinical trials will test how well the antibodies work for three groups: people who are hospitalized, those who are mildly ill and those who have been exposed to someone with the virus. The product will be given as an infusion for people who are sick, and as a lower-dose injection when it is used for prevention. The preliminary results are expected by late summer.
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