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Iterum Therapeutics plc (ITRM)
NasdaqGS - NasdaqGS Real Time Price. Currency in USD
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At close: 4:00PM EDT
3,350 reactions on $ITRM conversation
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I suppose nobody had any real confidence in this being approved on the 25th. We will see what happens Monday. Sad that the company didn’t fill in shareholders. I still have confidence that they will come out on top.
“During three phase 3 trials of sulopenem, the drug was compared to the FDA-approved antibiotic ciprofloxacin. The data indicated statistical superiority over ciprofloxacin without any significant adverse events.
I work for a medical manufacture and we just went through this same process. We received the same letter from the FDA for our labeling. It took us 2 weeks to submit the corrections and the FDA sent us our approval letter the weekend of the due date. Not saying that this is what will happen here but based on my experience, I'm doubling down!
Those who are invested in bio tech or pharma company has to be patience the ROI is normally more than 6 X
Whether is approve on 25th July or not this is going to be approved soon in next one or two quarter.Is only hiccup since they are at level 8 and 9 of FDA list. So chill guys !!!
Holding 30K+ shares. Let's all be a bit realistic. Looking at how the letter that was received by Iterum earlier this month by the FDA plays out in 100% of all biopharmaceuticals that have historically ever received this type of letter (albeit exact wording is not always rubber stamped from letter to letter), a complete response letter is always issued by the FDA. 80 % of those companies go on to successfully still bring their drug through FDA approval, but it just takes time and patience. That time could be months or a couple of years but the odds are in the company's favor. So hang tight, if you are in this for a short term trade/swing/gain, then better to sell while above a dollar. Realistically, it will dip below a dollar but how low is anybody's GUESS. In the bigger picture, with approval (80% chance after crl), it will skyrocket. Just depends on what your goals and risk tolerance are.
one more thought, so.. why would the FDA send a letter about how there’s deficiencies? My theory is, they are letting
know that they should fix a few minor issues before the 25th so that they can approve them. Otherwise, why would they postpone? Why would they give a heads up to correct something? They would just reject all at once if it wasn’t good. 🤔💭💭💭💭💭
If deficiency letter is true, and only stops at labeling, and marketing. Why would FDA waist their precious time to discuss POST - Marketing issues on a drug that was not effective? Key word being "Post." I truly believe an approval is on the horizon if this is the case. Million dollar question , when will all our dead money be turn into hard earned cash.
Win-Win situation for ITRM investors. If approved over the next few days we make a lot of money. If delayed via CRL, we double down and make even more upon approval in the near future. FDA approval is imminent
If they do end up with a CRL then they are still likely to be approved after addressing the deficiencies. After going through a history of CRL that has occurred in 2016-2017.. they were all eventually approved. Some had expedited reviews and some took as long as over a year. I believe if you have gotten in at a higher price then it may be best to hold on and let this ride. You have just become an investor :)
fine with delay, down with rejection and cheers with approval (when it happens).
I am light now, so fine if it go down a bit and may double down. GL!
Buy low sell high club
Last minutes to get in....weekend we should get the news of approval...or delay...
News will be CRL. If you are buying in now gambling on approval you shouldn't be trading biotech.
I've got a questions folks. I'm bought in at 1.09 and now holding a bit over 25k shares. Let's say, this doesht end up getting an fda approval, will this go below 0.50? How low can the price go? Seeing ardx tanking this evening, kind of got me down. Hope it really gets one though!
Share price will now move very quickly to $6-7.00 range on approval. What some of the previous weak hands should be upset about is the dark tone of the PR after the FDA notification. Totally unwarranted and it scared a ton of shareholders out and allowed the deep pockets to load up at fire sale prices. The spike could top out at $10-12 before settling in 6-7 range.
Is it true that FDA identified Sulopenem as a priority Drug??
Shorts better hope they, or someone they love, never gets a UTI which goes untreated with current medications. My wife struggled for years, thus our discovery and investment in ITRM. Hoping for approval so many lives can be improved.
The entire landscape is set for approval. Huge need, regulatory burdens minimized for abx, extended patent protections. The published data is that it works, period. Scope and label may be narrow but unless they find a safety issue, this should get approved.
Patience is the key. One day the drug will be approved.
Interesting they provided ITRM a update 3 weeks before the final PDUFA date. Why not just wait to the last day, then slash their tires on approval? Almost seems like they are giving them a heads up beforehand. Whomever assessed the application had to have done a thorough review. Labeling and marketing feel like the final criteria checks. Which would mean everything in between was solid. It may seem this was on track to being approved early without the labeling setback. I commend the company for not panicking information to shareholders. We were told exactly what they were told, and they didn’t question the problem. I believe they are hard at work, and 3 weeks time the issues will be resolved then BOOM we go.
Once approved; Sunday or 6 Sundays away, PFIZER BUYOUT…
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