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Message: Re: Odd
Odd
6
Dec 08, 2020 01:43AM

Paladin, nothing is odd, you just looked the wrong place. Here is why.

There are only 23 drugs on the list you found, but according to the FDA website (https://www.fda.gov/drugs/ind-activity/breakthrough-therapy-designation-requests) there were a total of 51 granted BTDs. Thus, at least 28 other drugs were 'ignored' by the list you found. Already there, we have an important detail worth noting.

Here comes the only version that is well supported by facts:

Resverlogix has received a BTD as Resverlogix unequivocally communicated, but we cannot see it on the FDA website because FDA does not have a list of granted Breakthrough Designated (BTD) drugs  - such information is most likely considered confidential and the FDA should not share confidential information with the public. What the FDA can show without breaching any confidentiality is that they have granted breakthrough designation to 51 drugs - note that no names are given - it is just the total. What you found was a list of approved BTD drugs. Thus, when a BTD granted drug finally gets approved by the FDA - where approved means approval of the drug for commercial use (not just the BTD designation), it becomes a public announcement by the FDA, and that is when the FDA can show the names of the drugs/companies. And, yes, that list currently contains 23 drugs - here it is (you need to click on Current CY CDER BT approvals):  https://www.fda.gov/drugs/nda-and-bla-approvals/breakthrough-therapy-approvals count the drugs, there are 23 such approvals.

There is absolutely no reason to question the fact that RVX has received a BTD for Apabetalone. They have received that designation for good reasons - Apabetalone is truly a breakthrough therapy that may mitigate and even reverse a number of age related symptoms - including cardiovascular diseases.

In general, please use links that support your findings/questions - it helps when researching the facts.

While we are all very impatient with Resverlogix, we should be careful not to believe conspiracy-looking theories - the truth is typically the least exciting option, but because of a desire for excitement among users of the internet, internet media tend to propagate the stuff that people click on, and that is the exciting stuff - which unfortunately often lacks in truth.

BR.

BKC

 

 

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