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18:47
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Originally posted by Chatterbox
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Once in the patient I suspect you'll find out within a opulent of days if the drug does what we all hope for. However, that is not necessarily the bottleneck to a speedy approval. They've had conversations with the FDA which could be great. If the RCE team was well prepared and the paperwork on production process of the drug has no flows they will have received good feedback on the clinical trial setup. Assuming so, they should now know more about number of patients they need to recruit for phase 1 and other parameters. Possibly similar for a phase 2, or maybe even multiple phase 2 trials and other test that need to be done (for example safety tests with regards to reproduction). All these are extremely expensive so they'll need extra funds first I'd imagine. They have to identify a suitable company that's going to run the trial, recruit doctors and suitable patients etc. reporting on the trial outcomes will also take probably a month or 2 at least. Put the case together to take to the FDA and before you know 2 years have gone by. Let's just say that that I'd be very impressed if they get to approval within a 2 year period. There will be a lot of pressure from regulators to keep prescriptions of new antibiotics to an absolute minimum for very good reasons, novel mechanism of action or not. Bacteria will over time adapt and the only way we can prolong that period is by restricting the use to only absolutely necessary cases. So far the developments are exciting, certainly from a medical point of view. If this drug is going to deliver great $ value to investors remains to be seen though but approval is not around the corner as some people seem to think. I got annoyed with the frequent speculations I guess. That all I want to say about this now
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Thanks Chatterbox. We should all know more soon enough, but until then I guess HC is a good place for us to all share our speculations, hopes, dreams and maybe the very occasional well educated analysis.
(20min delay)