Great, Mo. It's bogus to compare Brilacidin-OM to
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Posted On: 04/17/2019 6:26:14 AM
Great, Mo. It's bogus to compare Brilacidin-OM to that old approval statistic and claim that there is only a 55% chance of approval for other reasons in addition to the changes in the FDA's policies
Why do I say that?
Because those statistics include ALL drugs that applied for approval. This means that included in that statistic are all the failed Alzheimer's drugs, schizophrenia drugs, and drugs for other diseases that are notoriously hard to treat and for which a "successful" clinical trial has such low efficacy that the FDA would not approve them -- because the side effects were so severe for so many people, while offering little benefit.
One cannot compare the entire spectrum of drugs, many of which have severe side effects, with Brilacidin-OM, which has NO side effects, and is NOT A SYSTEMIC DRUG but instead is locally applied via swish-and-spit.
Bril-OM's great safety profile is the game changer. Safety will not be a concern for the FDA or EMA. Efficacy will be -- and the Phase 2 results show great efficacy, for a condition that has NO treatment now.
The chance of a drug being approved when there is no current treatment is much, much higher than when there are already some approved treatments.
There is another possibility too --
It's possible that at least in the EU Brilacidin-OM could be considered a MEDICAL DEVICE rather than a drug. There are precedents for other type of medications which are not ingested, but applied internally, to be considered medical devices in the EU. One example is a company that has an antiseptic (not an antibiotic) that is kept in the port when a permanent line is implanted. These ports are notorious for causing serious infections. The antibiotic is kept in the port when it's not being used to introduce a drug to the body -- but removed each time when the port is used. You can see that a swish-and-swallow is much less invasive and has less chance of systemic effect than something like that. Yet, that antiseptic is considered a medical device.
Medical devices have a much, much higher rate of approval, if IPIX chooses to try to follow that root.
The good thing about Lemoncat's bogus claim is that with that post, he has proven what we have known all along -- some basher identities try to masquerade as bulls, until they become panicked enough to show their hand.
Why do I say that?
Because those statistics include ALL drugs that applied for approval. This means that included in that statistic are all the failed Alzheimer's drugs, schizophrenia drugs, and drugs for other diseases that are notoriously hard to treat and for which a "successful" clinical trial has such low efficacy that the FDA would not approve them -- because the side effects were so severe for so many people, while offering little benefit.
One cannot compare the entire spectrum of drugs, many of which have severe side effects, with Brilacidin-OM, which has NO side effects, and is NOT A SYSTEMIC DRUG but instead is locally applied via swish-and-spit.
Bril-OM's great safety profile is the game changer. Safety will not be a concern for the FDA or EMA. Efficacy will be -- and the Phase 2 results show great efficacy, for a condition that has NO treatment now.
The chance of a drug being approved when there is no current treatment is much, much higher than when there are already some approved treatments.
There is another possibility too --
It's possible that at least in the EU Brilacidin-OM could be considered a MEDICAL DEVICE rather than a drug. There are precedents for other type of medications which are not ingested, but applied internally, to be considered medical devices in the EU. One example is a company that has an antiseptic (not an antibiotic) that is kept in the port when a permanent line is implanted. These ports are notorious for causing serious infections. The antibiotic is kept in the port when it's not being used to introduce a drug to the body -- but removed each time when the port is used. You can see that a swish-and-swallow is much less invasive and has less chance of systemic effect than something like that. Yet, that antiseptic is considered a medical device.
Medical devices have a much, much higher rate of approval, if IPIX chooses to try to follow that root.
The good thing about Lemoncat's bogus claim is that with that post, he has proven what we have known all along -- some basher identities try to masquerade as bulls, until they become panicked enough to show their hand.
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