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Iterum Therapeutics plc (ITRM)
NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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4,160 reactions on $ITRM conversation
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Pure speculation…wouldn’t be surprised if Pfizer acquired Iterum very soon and carried the batton over the FDA approval finish line. They are loaded with cash and certainly have to political clout to do so…maybe wishful thinking, but certainly very possible
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Why is there a hangup based on the "non inferiority" results when its within 2% of the control drug?
That isn't the criteria for approval is it, because the FDA's own document says that it isn't the purpose for a non-inferiority design.
This should have been approved already. Its basically JUST AS EFFECTIVE as already-approved drugs.
BOTTOMS IN. WHAT A GREAT OPPORTUNITY TO BUY. THIS IS ONE NEWS AWAY FROM GOING PARABOLIC. THE WORLD NEEDS THIS DRUG SOONER OR LATER. WHAT OTHRR COMPANY IS WORKING ON THIS???
Long term bag holder here. Its clear from previous FDA interaction this is a tricky one and they probably needed more than one meeting to get an agreed study design. Hence no PR. Plus - ambulance chasers watching them like hawks. This is a 2 year hold from here.....which will make 4 years in total for me!!!!!
Just my epinion
Total Cash (mrq) 88M
Total Cash Per Share (mrq) 0.48
Stock closed at 0.33
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On page 17 of co website only January release it is mentioned that << did not achieve …. By 1 patient>>.
Earlier in the presentation, … non inferiority end point missed solely due in inclusion of asymptomatic bacteriuria …. which is usually not treated with antibiotics.
Could it be that co is right now in argument with FDA because of this issue ?
It would be interesting to see study released without incorporating asymptomatic bacteriuria in the mix.
For sure some clarity would be appreciated.
I had a weird feelings on this antibiotic.
Delayed type B meeting meaning that it will be approved without another additional trial phase 3 or small trial uUTI for dose regiment (500mg instead 1000mg)??????
CB... you are right, release now on co website indicates that type B meeting with FDA did happen in December.
Thank you for the info.
Unfortunately, no inside track but timing is such that some news should be released soon. Hopefully/should be something good related to type B meeting.
I am little mad becouse there is still no news about a meeting. I am here for 1 more year for sure, but not gona add until some news come out. We are bagholding and it is irritating.
BUT, cannot understand why no official PR about this type B meeting.
At this stage, is it not very important/relevant news ?
Got my .35 buy order in. Anyone else?
Type B meeting happened in December. FYI, BIg D.
Shared their presentation for this weeks presentation which says so but Yahoo in their awesome wisdom kills most posts with links added.
.39 buying again, I guess. Inclined to wait for .35 at this point. Good luck. Still waiting for you to share that presentation Bruce. You know the one that says the type B meeting already happened.
I am but till I see 3 to seek
Bin Salman aka MBA
everyone ready for a new week of lows
Any news about the FDA approval 🚀
Info about phase 3 extension was evidently not released in December.
What about, it, Looking pretty sure for January ?
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