Iterum Therapeutics PLC (ITRM) ニュース

Huh? Whatever you say... 
this stock is primed for a huge breakout soon. Chart beauty, and buyout news is just pending. They won't sell such a premium product for chump change. 

With EX pumping here ITRM will follow OTLK imo

100%! The approved drug is worth 300-500 million, and maybe this is even a conservative figure. Just look at the market cap and connect the dots... Have a nice weekend

ITRM....................https://stockcharts.com/h-sc/ui?s=ITRM&p=W&b=5&g=0&id=p86431144783

Ya think it can really go that high?

It depends. The fda approval makes this stock worth more than 10$. Not sure when book value and reality are going to match...

YEAH NO...BIT LATE SON EEARLY BIRD GETS THE WORM

there still time to jump on this or you think there is a pullback coming?

ITRM MONSTER

ITRM...................................https://stockcharts.com/h-sc/ui?s=ITRM&p=W&b=5&g=0&id=p86431144783

ITRM BREAK OUT

I know! And that could mean 15-20$. But most don´t even have the patience to hold until eow and are not able to stand a red day on the long way up and away...

Not much patience needed. This will be likely be over before Spring.

This stock is going to really bust! Most don't have that needed patience...

ITRM GAPPING AS WE APPROACH BREAK OUT...PLAY WITH CAUTION

If I’m not in a stock it busts out
If I’m in it tanks is my usual scenario

In the end no matter what people on message boards say. The fundamentals in here are plain and simple great! I expect it to really astonish people soon - esp. when you're not in 😉

ITRM BREAK OUT PLAY FDA BIO MONTHS AGO

Huh? No need to pump! FDA approval is a given fact!
Just ignore KIPK.

He is pissed off on another stock (NWBO, where he is banned on this board) about my negative posts. So he follows me around like a stalker and posts idiotic comments on any stock I discuss.

Huh? No need to pump! FDA approval is a given fact!

OTLK that EX been pumping just crashed; failed trial

Beware of paid pumper/basher EX....................

But the final number gonna be 5-10 times above our market cap rn around 2$...

The game plan is to monetize by selling off either rights to the drug or the company. Either way all is over and all we can do is wait on the final number.

Sounds about right my friend

Never left the boat! Added lows, no hurry to sell my shares. Expect 10$+

Where is everyone lol
A buyout is coming to town

Very important drug. Big pharma like Pfizer may come calling or has called already

Gonna be a multi day run imo

ITRM..................https://stockcharts.com/h-sc/ui?s=ITRM&p=W&b=5&g=0&id=p86431144783

Excellent

Label is about as expected. They did recommend culture testing (to insure proper agent is used for specific bug), bt did so in a general way that implies it is universal. No black box (was mentioned as possible to warn against creating resistence).

Stuck in this halt but up 13% not  complaining 
1.40+ 20%

Agree

Big Pharma bribes, rules and runs the FDA its the American way of doing business meanwhiles urinary tract infection a big markets

Any strength shown is met with selling

Plus it’s not right to tie the company’s hands and restrict their ability to sell a product which will actually help people by having specific instructions on labels.

I tend to think if this was a big company such as Merck or Pfizer we wouldn’t have this issue

Yes it sounds like there will be some stipulations the FDA will enact.
It’s a shame! I understand the bug resistance aspect being in the medical field tho.

Im still a believer in the MD’S being the problem of which they don’t want to take full responsibility.
The FDA shouldn’t punish a biotech company for developing a new product which is needed. The AMA needs to do a better job of educating the educated 😆

I went through the ADCOM material a few weeks ago, but mainly from the pov of understanding what the FDA analysis was. I am very comfortable the FDA is willing to bless sulo as being safe and effective, the only open question is how to try to restrict use to avoid resistance.

Replaying it and listening more closely to the details of the discussion of creating resistance, I can understand how this is a tough issue to tackle.

The proposed label by ITRM (designated susceptible micro-organisms) is clearly a non-starter. Nobody at the ADCOM could even say what that means, and even if they could, the family doc is not about to call for a several hundred dollar test just to prescribe a cheap pill that almost always "works". Alternatives such as use after failure or use for resistant bugs had no supportable data,. Certainly a problem for the FDA, but they will find some label that expresses the concern.

I would be certain they will exclude use as a step down following IV treatments. I suspect they will somehow say use for cases where the doctor finds treatment via augmenten is not suitable.

I would not at all be surprised to see the FDA go off the farm and issue a black box against abuse due to risk of generating carbo-penum resistant bugs.

I wold be certain there will be a REMS and/or post approval study on these issues.

On the broader issue of antibiotic management, I was encouraged everybody took it seriously. I was discouraged that most all felt the community docs will broadly ignore it and take the easy way out.

.

Yes! Cipro and augmentin have been around for a long time.
It will take a while for the bugs to become resistant to this one.
And yes the doctors are the ones that caused this over prescribing. They give it away like candy and use it as a prophylactic after just about every surgery

For some explanation on that subject, the absurd off-label use of all antibiotics is a huge issue. That is true for all, nothing specific here. Go to most any third world or developing country and you can buy Cirpro for a few bucks for 2 weeks(?) worth, no prescription.

This is what is causing the problem with "super bugs". So yes, the FDA has a concern here.

OTOH, the same thing is why we need more choice in the field of antibiotics. And that is what this is, another choice for bugs that are are resistent to other antibiotics.

AI Overview
According to recent updates, the FDA appears to be leaning towards approving Sulopenem for the treatment of uncomplicated urinary tract infections (uUTIs), but with significant concerns regarding antimicrobial resistance and the need for careful monitoring through post-marketing surveillance to ensure appropriate usage; the FDA Advisory Committee acknowledged the potential benefit for a subset of patients while emphasizing the importance of managing off-label use and potential impact on antimicrobial resistance if approved.

Sounds like the drug works well. FDA has to have the appropriate usage on the label it sounds like

Odds of approval are high, but I would not expect a huge gain.

Maybe up to $2-3 on thumbs up. Certainly down to almost $0 on thumbs down.

Again, I think the odds are good, so a good bet. Just think this is not one of those huge jumps you see on some drug approvals.

Any believers their drug gets approved Oct 25th?
Should fly if it does

dang it should have run right after you sold

No update or feedback, I dumped all shares

Anyone understand the strategic planning behind the dilutive prospectus?
ITRM wants to raise cash now in the event the NDA Hearing is not good?
Or ITRM wants to raise cash now to hit the ground running with advertising after the successful NDA Hearing(s) in Sept and Oct.?
One indicator will be after subscription rights end 5 PM on August 6. Did investors jump on this or luke-warm maybe?

Good News https://www.iterumtx.com/news/press-releases/detail/124/iterum-therapeutics-receives-fda-acceptance-of-resubmission

ITRM.......................https://stockcharts.com/h-sc/ui?s=ITRM&p=W&b=5&g=0&id=p86431144783