[BostonCard]

So, under normal circumstances, a pharma company will propose a threshold of efficacy and safety data that would support a particular indication, and the Agency will (often) push back, either demanding a larger safety database, or more robust evidence of efficacy.  Now it looks like that relationship has been turned on its head.

https://www.bloomberg.com/news/articles/...f=leQ3i2ya

With the Agency (under pressure from the administration) all but begging vaccine makers to bring a vaccine for EUA by late October (gee, I wonder why might that date be important?), the makers are pushing back, publicly pledging that they won't send the data for review without "extensive" safety and efficacy data.

Trump deserves a lot of credit for really pulling out all the stops to get a vaccine for COVID to where it is now and possibly to approval before the end of the year.  Whether it gets approved before November 3 or after is really beside the point, because it is starting to look increasingly likely that something people said would take 12 to 18 months if everything went right could be accomplished in less time than that.  Trump has done a lot of things wrong, but putting government muscle into accelerating vaccine development is one thing he's exceeded my expectations.  I just hope he doesn't blow this by pushing an artificial deadline related to the political calendar at it.

BC

[BostonCard]

So, under normal circumstances, a pharma company will propose a threshold of efficacy and safety data that would support a particular indication, and the Agency will (often) push back, either demanding a larger safety database, or more robust evidence of efficacy.  Now it looks like that relationship has been turned on its head.

https://www.bloomberg.com/news/articles/...f=leQ3i2ya

With the Agency (under pressure from the administration) all but begging vaccine makers to bring a vaccine for EUA by late October (gee, I wonder why might that date be important?), the makers are pushing back, publicly pledging that they won't send the data for review without "extensive" safety and efficacy data.

Trump deserves a lot of credit for really pulling out all the stops to get a vaccine for COVID to where it is now and possibly to approval before the end of the year.  Whether it gets approved before November 3 or after is really beside the point, because it is starting to look increasingly likely that something people said would take 12 to 18 months if everything went right could be accomplished in less time than that.  Trump has done a lot of things wrong, but putting government muscle into accelerating vaccine development is one thing he's exceeded my expectations.  I just hope he doesn't blow this by pushing an artificial deadline related to the political calendar at it.

BC

[OutsiderFan]

I just hope he doesn't blow this by pushing an artificial deadline related to the political calendar at it.

What else could possibly be the motivation? That he cares about anyone but himself?
LOL

If you have bothered to follow how his deranged mind functions, this is how things will most likely play out. If there is no vaccine approved by Nov. 3, it will no longer be discussed as a priority. If he loses, the FDA will be ordered not to approve a ready vaccine out of spite, and will only get approval when the FDA is allowed to do what it thinks is best, unless the FDA sees a lame duck and starts doing what it wants against White House wishes.

It’s even entirely possible that even without vaccine makers applying for vaccine approval, the White House and CDC continue saying a vaccine is coming by Nov. 1, against all evidence, until they finally have to admit it won’t happen.

[OutsiderFan]

I just hope he doesn't blow this by pushing an artificial deadline related to the political calendar at it.

What else could possibly be the motivation? That he cares about anyone but himself?
LOL

If you have bothered to follow how his deranged mind functions, this is how things will most likely play out. If there is no vaccine approved by Nov. 3, it will no longer be discussed as a priority. If he loses, the FDA will be ordered not to approve a ready vaccine out of spite, and will only get approval when the FDA is allowed to do what it thinks is best, unless the FDA sees a lame duck and starts doing what it wants against White House wishes.

It’s even entirely possible that even without vaccine makers applying for vaccine approval, the White House and CDC continue saying a vaccine is coming by Nov. 1, against all evidence, until they finally have to admit it won’t happen.

[Mick]

I just hope he doesn't blow this by pushing an artificial deadline related to the political calendar at it.

What else could possibly be the motivation? That he cares about anyone but himself?
LOL

If you have bothered to follow how his deranged mind functions, this is how things will most likely play out. If there is no vaccine approved by Nov. 3, it will no longer be discussed as a priority. If he loses, the FDA will be ordered not to approve a ready vaccine out of spite, and will only get approval when the FDA is allowed to do what it thinks is best, unless the FDA sees a lame duck and starts doing what it wants against White House wishes.

It’s even entirely possible that even without vaccine makers applying for vaccine approval, the White House and CDC continue saying a vaccine is coming by Nov. 1, against all evidence, until they finally have to admit it won’t happen.

Trump will undoubtedly claim that but for him, the COVID pandemic would have been even worse.  Obviously that is undoubtedly untrue.  The American pandemic experience has been awful, thanks to Trump, literally the worst of both worlds, getting a shutdown and a ruined economy, then a rapid re-opening with off-the-charts infections.

I imagine that Trump thought his only saving grace would be to promise a vaccine before voting day and "encouraging" the FDA to play along.  He's painted himself into a corner, though.  What will happen to the presidential vote when the pharmas collectively say "no, sorry, we've made progress at an unbelievable rate, but there's no vaccine."  There's your late October/early November "surprise" right there, when Biden lists it as perhaps the most important of Trump's 20k lies.

Hope it works.  The gap between Trump's approval/disapproval rating has been dropping over the last four months.  It's now less than 9%, from a high of almost 16%.  

https://projects.fivethirtyeight.com/tru...l-ratings/

[Mick]

I just hope he doesn't blow this by pushing an artificial deadline related to the political calendar at it.

What else could possibly be the motivation? That he cares about anyone but himself?
LOL

If you have bothered to follow how his deranged mind functions, this is how things will most likely play out. If there is no vaccine approved by Nov. 3, it will no longer be discussed as a priority. If he loses, the FDA will be ordered not to approve a ready vaccine out of spite, and will only get approval when the FDA is allowed to do what it thinks is best, unless the FDA sees a lame duck and starts doing what it wants against White House wishes.

It’s even entirely possible that even without vaccine makers applying for vaccine approval, the White House and CDC continue saying a vaccine is coming by Nov. 1, against all evidence, until they finally have to admit it won’t happen.

Trump will undoubtedly claim that but for him, the COVID pandemic would have been even worse.  Obviously that is undoubtedly untrue.  The American pandemic experience has been awful, thanks to Trump, literally the worst of both worlds, getting a shutdown and a ruined economy, then a rapid re-opening with off-the-charts infections.

I imagine that Trump thought his only saving grace would be to promise a vaccine before voting day and "encouraging" the FDA to play along.  He's painted himself into a corner, though.  What will happen to the presidential vote when the pharmas collectively say "no, sorry, we've made progress at an unbelievable rate, but there's no vaccine."  There's your late October/early November "surprise" right there, when Biden lists it as perhaps the most important of Trump's 20k lies.

Hope it works.  The gap between Trump's approval/disapproval rating has been dropping over the last four months.  It's now less than 9%, from a high of almost 16%.  

https://projects.fivethirtyeight.com/tru...l-ratings/