5 ms·

> there was been no efficacy nor safety studies conducted with the exact Bonjesta formulation Would you expect this? Not every drug on the market goes through

> there was been no efficacy nor safety studies conducted with the exact Bonjesta formulation Would you expect this? Not every drug on the market goes through safety and efficacy tests of their exact formulation do they? The point of safety and efficacy testing is to establish that it’s safe and effective, and this can be done in general for a drug, and then múltiple different formularios might enter the market. You don’t redo crash tests of cars because you change the interior lining.

ekianjo 4y ago
> Not every drug on the market goes through safety and efficacy tests of their exact formulation do they you are supposed to test the actual formulation in clinical trials, not "some mix that is kind of similar". In safety studies (Phase 1) you can get away with testing something different (i.e. much higher doses) because you want to prove that the drug is safe for use. But Phase 2 is usually where you decide on the final formulation by having several options, and Phase 3 is the final drug tested "as is" before it reaches the market. The formulation is not some kind of cosmetic property, it impacts dissolution speed, bio-availability and many other parameters that can change how the drug works. Some minor adjustments can be made to the formulation between Phase 3 and commercialization but there are strict guidelines on how to justify such changes. In any case, Bonjesta has apparently done no such trials based on the publication referenced. > You don’t redo crash tests of cars because you change the interior lining. Bad analogies are bad analogies.
- isitmadeofglass 4y ago
  So your arguing that they are illegally marking this despite FDA rules and regulations? Yea, thought not. So we agree that they are following the rules. So this whole “you are supposed to do …” doesn’t really constitute an argument. Also both arguing that the drug is overpriced because it’s just a combination of two other available drugs that you could just buy separately and take together, and then also arguing that they should have conducted a separate tox and efficacy study on the exact formulation they are using is crazy. And you state it yourself in your argument, you are allowed to make changes to the formulation, and not suprimo no Ku they where allowed. And they are not illegally marketing this, so what on earth is your argument?

ekianjo 4y ago

> Not every drug on the market goes through safety and efficacy tests of their exact formulation do they you are supposed to test the actual formulation in clinical trials, not "some mix that is kind of similar". In safety studies (Phase 1) you can get away with testing something different (i.e. much higher doses) because you want to prove that the drug is safe for use. But Phase 2 is usually where you decide on the final formulation by having several options, and Phase 3 is the final drug tested "as is" before it reaches the market. The formulation is not some kind of cosmetic property, it impacts dissolution speed, bio-availability and many other parameters that can change how the drug works. Some minor adjustments can be made to the formulation between Phase 3 and commercialization but there are strict guidelines on how to justify such changes. In any case, Bonjesta has apparently done no such trials based on the publication referenced. > You don’t redo crash tests of cars because you change the interior lining. Bad analogies are bad analogies.

isitmadeofglass 4y ago
So your arguing that they are illegally marking this despite FDA rules and regulations? Yea, thought not. So we agree that they are following the rules. So this whole “you are supposed to do …” doesn’t really constitute an argument. Also both arguing that the drug is overpriced because it’s just a combination of two other available drugs that you could just buy separately and take together, and then also arguing that they should have conducted a separate tox and efficacy study on the exact formulation they are using is crazy. And you state it yourself in your argument, you are allowed to make changes to the formulation, and not suprimo no Ku they where allowed. And they are not illegally marketing this, so what on earth is your argument?