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Posted On: 10/27/2021 9:23:09 PM
Post# of 148892
It's going to take a lot more than reddit posts and a couple singled out emails to sway me from the overwhelming scientific evidence and potential of Leronlimab.
As in anything that gets discussed these days, you can find a treasure trove of relevant information just hanging out on the interwebs waiting for you to swing by for a look. For instance, let's take a break from bitching about out-of-context words, or Amarex sucking at a level Hoover could never achieve, and look around at a couple world wide websites.
Here's one:
https://www.bio.org/sites/default/files/legac...202016.pdf
This is a study of all NDA (new drug applications) and BLA (biologics license applications) over a ten year period to see what the chances of approval looked like. There's a handy table that shows the success rate of these drug candidates broken down by disease state and the percentage that were successful on the first, second, or (as mentioned in the presentation it can be up to 4 times) eventual approval, including the time it takes from submission to approval on average. Spoiler Alert! It isn't that great. The average time from submission to approval is 1.6 years. And the first attempt success rate for companies with an autoimmune drug candidate are 63% while the overall (all disease) average is only 61%.
The good news is that the eventual success rate of companies that have gotten to the BLA or NDA stage is actually a good bit higher at 86% across all disease states.
A couple other relevant notes from the article/presentation:
" During the time frame of this study (2006-2015), programs entering clinical development in Phase I were found to have only a one in ten (9.6%) chance of advancing all the way to FDA approval."
"The higher success rates for trials run with biomarker-selected patients suggests that the broader industry is already on the right path. For example, Phase III transition success rates in programs utilizing selection biomarkers in the last decade were 76.5% (n=132) compared to only 55.0% (n=1,254) for non-biomarker trials."
"These rates are the result of eventual success, not success on first review, meaning some programs may have as many as four Complete Response Letters (CRLs) and attempts at approval."
Oh hey! Here's another one from 1992 and I'm guessing it's gotten harder, not easier:
https://www.cato.org/sites/cato.org/files/ser...indication.
"If the drug still appears to be promising, the firm submits the results of the trials to the FDA in the form of a new drug application. Applications are typically 100,000 pages long . Finally, the FDA will approve the drug as a treatment for a specific indication."
"Of the 80 to 250 new drug applications firms file annually, the FDA approves only 20 to 60. Many of those represent reformulations of existing products. In all, firms will market about one out of a hundred of the products for which they have developed patents." (That's a hit rate of 20-25% way back in 1992. Clearly it has never been all that easy to get a drug approved)
OK, let's do one more:
BLA Submission Reform is on its way.
https://tinyurl.com/45prd4rs
So maybe give this small team that's doing their best a little bit of a break, eh? Over the course of 7 years, hundreds of thousands of pages of compiled data, a global pandemic, the FDA changing the HIV dose at the last minute, BP trying to steal the company's IP, Amarex being inept, "hidden" forces attacking the company to drive the share price down, and a variety of other issues, maybe getting butt hurt about a single email (presented without the rest of the conversation) is more than a little ridiculous.
#NecessaryButtStuff
As in anything that gets discussed these days, you can find a treasure trove of relevant information just hanging out on the interwebs waiting for you to swing by for a look. For instance, let's take a break from bitching about out-of-context words, or Amarex sucking at a level Hoover could never achieve, and look around at a couple world wide websites.
Here's one:
https://www.bio.org/sites/default/files/legac...202016.pdf
This is a study of all NDA (new drug applications) and BLA (biologics license applications) over a ten year period to see what the chances of approval looked like. There's a handy table that shows the success rate of these drug candidates broken down by disease state and the percentage that were successful on the first, second, or (as mentioned in the presentation it can be up to 4 times) eventual approval, including the time it takes from submission to approval on average. Spoiler Alert! It isn't that great. The average time from submission to approval is 1.6 years. And the first attempt success rate for companies with an autoimmune drug candidate are 63% while the overall (all disease) average is only 61%.
The good news is that the eventual success rate of companies that have gotten to the BLA or NDA stage is actually a good bit higher at 86% across all disease states.
A couple other relevant notes from the article/presentation:
" During the time frame of this study (2006-2015), programs entering clinical development in Phase I were found to have only a one in ten (9.6%) chance of advancing all the way to FDA approval."
"The higher success rates for trials run with biomarker-selected patients suggests that the broader industry is already on the right path. For example, Phase III transition success rates in programs utilizing selection biomarkers in the last decade were 76.5% (n=132) compared to only 55.0% (n=1,254) for non-biomarker trials."
"These rates are the result of eventual success, not success on first review, meaning some programs may have as many as four Complete Response Letters (CRLs) and attempts at approval."
Oh hey! Here's another one from 1992 and I'm guessing it's gotten harder, not easier:
https://www.cato.org/sites/cato.org/files/ser...indication.
"If the drug still appears to be promising, the firm submits the results of the trials to the FDA in the form of a new drug application. Applications are typically 100,000 pages long . Finally, the FDA will approve the drug as a treatment for a specific indication."
"Of the 80 to 250 new drug applications firms file annually, the FDA approves only 20 to 60. Many of those represent reformulations of existing products. In all, firms will market about one out of a hundred of the products for which they have developed patents." (That's a hit rate of 20-25% way back in 1992. Clearly it has never been all that easy to get a drug approved)
OK, let's do one more:
BLA Submission Reform is on its way.
https://tinyurl.com/45prd4rs
So maybe give this small team that's doing their best a little bit of a break, eh? Over the course of 7 years, hundreds of thousands of pages of compiled data, a global pandemic, the FDA changing the HIV dose at the last minute, BP trying to steal the company's IP, Amarex being inept, "hidden" forces attacking the company to drive the share price down, and a variety of other issues, maybe getting butt hurt about a single email (presented without the rest of the conversation) is more than a little ridiculous.
#NecessaryButtStuff
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