RE: As a change from the incessant droning of some ppl...19 Feb 2020 10:10
Stages of antibiotic research and development (R&D)
The discovery process starts with basic research to identify organisms that produce antibiotic substances (sometimes in surprising places, such as the Komodo dragon blood(opens in a new tab), ants(opens in a new tab) or inside the human nose(opens in a new tab)).
Thousands of possibilities are tested, which can take years. While it’s easy to find substances that kill bacteria, it’s much more difficult to discover and develop substances that are not also toxic to humans.
Promising candidates found in pre-clinical development move into clinical trials, where the new drugs are tested to see if they’re safe and effective in people. Clinical trials, which usually run in three phases, are even more expensive and complex. They require resources, infrastructure and expertise that can only be provided by large pharmaceutical companies.
The final phase of trials – and the trials needed after an initial product launch – can account for more than 80% of the total R&D spend on a new drug.
If a new drug proves safe and effective, it needs to be registered with a government drugs regulator before being legally prescribed in a country. The approval process, which tends to be slow and full of regulatory hurdles, adds to the costs and the timeline.
More money is then spent on marketing. Despite these efforts, it can be very difficult to get doctors and health systems to buy and use new antibiotics. And, as the last line of treatment against certain infections, they need to be used sparingly to limit the development of drug resistance.
The annoying thing with iclaprim is that ALL above points have been completed! Still no approval. The last line of the above is all revealing ...."And, as the last line of treatment against certain infections, they need to be used sparingly to limit the development of drug resistance."
I would therefore hang my hat on the ONLY reason iclaprim did not get approval is because the FDA are keeping this on the back burner for emergencies. ie when planet earth (or the US army?) is in dire need of a new antibiotic.
Lumsden has got nothing to do with the failure to get this approved. But he has still made a load of dosh.
I wonder if iclaprim kills COVID 19?
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