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Post by ivyspivey on Oct 7, 2017 19:13:10 GMT
Q.What market segment are MTFB targeting for Iclaprim.
A.Specifically the renally impaired ABSSSI patient estimated to be 26% of 3.3m US patients pa or 936k at a patient treatment cost of $3000.
So expect 10% market share and peaking at 20% of $2.8bn opportunity so annual sales between $280-560m pa
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Post by pubesz on Oct 9, 2017 8:28:04 GMT
Hello ivy,
I am happy to find you here I hope you are well. So, as I understand well mtfb failed because of QTc issue in 2009.
I also understand that mtfb has done more trial on people and could improve a bit but not significantly.
I mean the resault was enough for the trial to hit but still there no significant efficincy between iclaprim and the other one which is on the market.
Do you think QTc still an issue here? I could not find any research about it.
If it is why we are confident that we can pass on fda next year?
Do not get me wrong please as I have a long position here but I'd like to think about mtfb as an investment rather than a trade.
I am looking forward to hearing from you.
ATB
pubesz
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Post by Darren on Oct 9, 2017 9:33:23 GMT
Hopefully Ivy will be along shortly.
From what I understand, the drug wasn't approved for a number of reasons, including:
- The attitude of the company that owned the drug at the time
- The cautiousness of the FDA at the time; there had been a drug approved which subsequently caused health issues. Iclaprim was one of 3 antibiotic drugs that didn't get approval around the same time. The other two have since been approved.
- The FDA changed the thresholds for approval half way through the study. The drug met the requirements of the original study parameters
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