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Re: DewDiligence post# 224655

Tuesday, 04/16/2019 1:02:02 PM

Tuesday, April 16, 2019 1:02:02 PM

Post# of 257628
AKAO

The bankruptcy filing is a shame.

I don't see how we are ever going to get new antibiotics when the FDA imposes such stringent clinical requirements on these companies that they can't get trials done at any sort of reasonable cost. Their BSI data were, in my opinion, more than sufficient for an indication even if some additional studies would be required.

And of course there is also the huge problem that any new antibiotic gets stuck at the very end of the treatment paradigm so sales of any new antibiotic are minimal. And the problem that the FDA keeps on layering on new Warnings and Precautions for adverse events that rarely occur and this makes new antibiotics appear to be much more dangerous than their older counterparts.

If we want new antibiotics we need a program in which the government provides very generous grants and guarantees to get them developed. In the absence of this it just isn't economically feasible to develop new agents.

I'd never invest in an antibiotic-focused company these days.

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