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I remain patient! It's about to happen, BO and explosion 💥
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
Ya think it can really go that high?
It depends. The fda approval makes this stock worth more than 10$. Not sure when book value and reality are going to match...
YEAH NO...BIT LATE SON EEARLY BIRD GETS THE WORM
there still time to jump on this or you think there is a pullback coming?
ITRM...................................https://stockcharts.com/h-sc/ui?s=ITRM&p=W&b=5&g=0&id=p86431144783
I know! And that could mean 15-20$. 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!
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
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%
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
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Fellow penny flippers, a week or 2 ago, someone posted about ITRM and it grabbed my attention immediately. Partially because its a Bio stock and another reason is the technical setup/gaps looked promising. I have dived into the company further and posting my DD:
Provide DD for bullish sentiment
Iterrum Therapeutics is a Biotech company backed by some very well known prominent industry veterns / team. There primary product is Sulopenum which is developed by Pfizer in the 1980s, shelved due to Pfizers other product focus. ITRM's staff is compromised of the well known bio legend - Alex Denner who owns Sarissa Capital. Alex Denner is more prominently known as the head of Carl Ichans bio division who spearheaded his portfolio and knows the Bio industry inside/out. Denner left Ichan's bio portfolio to spinoff Sarissa Capital and leverage his decades of knowledge. Sarissa Capitals' main focus in investing in bio stocks with the intention of buyouts (Denner & MDCO --- Medicines company buyout $9.7 billion.
A large majority of ITRM staff and board are from a very well known company back in 2005 Duratta / Vicuron boards. Back in 2005, Vicuron was developing a drug that passed the NDA for andidulafungin for fungal infections. Pfizer jumped in after NDA approval and bought Vicuron out for $1.8 billion as it was a revolutionary drug.
source: Pfizer buy out Vicuron $1.9 billion merger
What ended up happening at Pfizer was Vicuron had to now go through FDA approvals. From the little research available back then, it appears Vicuron ended up getting shelved as there was a lot of R&D involved and too expensive to push forward (Dunne link below shows Pfizer splitting off from R&D, trial, FDA approval costs). Vicuron ended up being bought by Durata (source: https://www.pharmaceutical-business-review.com/news/durata_acquires_vicuron_from_pfizer_091221-2/. Duratta picks up where Pfizer left off, conducted the studies, R&D, and NDA/FDA process. When Vicuron's drug become close, Duratta reached back out to Pfizer to continue the trial study to keep moving forward. Pfizer had to fork up another $6million apart of their licensing deal
(source: Faded star at Pfizer leads to discounted $68M IPO for Durata
What ended up happening 2 years later in 2014? Actavis buys out Durata for $675 million @ $23 a share, prior to buyout, stock was trading at $11. (source: Durata stock graph.
source: Actavis snaps up Durata, newly approved antibiotic in $675M buyout
After this buyout in 2014, ITRM was formed. A large amount of the Board of Directors, Senior Management are from the previous buyout. There prior Durata employees and now focusing their efforts on ITRM.
source: ITRM Board of Directors & Senior Mgmt
Sulopenum
Pzier chief scientist Michael Dunne left Pfizer to work at ITRM. He was the scientist behind a lot of Pfizer's major drugs. He currently resigned from ITRM for a new opportunity -- working as Chief Scientist at the Bill & Melinda Gates Foundation. Back in 2017 as he was speaking on behalf of ITRM / Sulopenum, he had a very strong positive sentiment to the drug when it gets the NDA / FDA passed:
While this is an old compound, sulopenem has good patent protection. The IV product should garner ten years of regulatory exclusivity in the U.S. due to its status as a “Qualified Infectious Disease Product”. Given that the oral form of sulopenem is an NCE, patent protection for this version exists through 2028 with the possibility of Hatch-Waxman as well as pediatric use extensions.
Source: Former Pfizer Scientist Is Resurrecting Projects To Solve The Multidrug Resistant Bacteria Problem
NDA Approval
NDA approval is set for end of January or potentially first week of February. They had a preliminary meeting back in Sept 2020.
Positive Pre-NDA Meeting with FDA for Sulopenem - 95% approval from ITRM Board
The same board members, staff, and ties on the Duratta deal are now working at ITRM. Almost all of ITRM employees are from Durrata. During the NDA filing review, Pfizer had some senior members during the NDA review with FDA (pre filing). Some names -- Treacy Vargas (worked at Pfizer for 17yrs, retired, and ITRM brought her out of retirement to be head of their submission applications). They brought her in on contract, then after they submitted the NDA in October, she left.
Sarissa Capital & Alex Denner
Alex & Sarissa are known from above link and many others of turning Bio companies in to large profitable buyouts. Sarissa currently owns 33% of ITRM with a special clause for obtaining 60% total ownership of the outstanding shares.
Sarissa discloses 33% ownership of ITRM
Alex& Sarissa have a clause where after Jan 21, they can invoke the exchange of exchangeable notes to take FULL ownership of ITRM after NDA approval. Sarissa AGM meeting for exchangeable notes. So they have a additional 27% ish to exchange if they want. Starting of the ability to exercise I think is Jan 21 from the filing: ITRM AGM Meeting & Sarissa Ownership clause vote
Current outstanding shares is roughly 70-85% are owned by Sarissa, RA Capital, and other institutions / insiders.
source:ITRM Share distribution / ownership
SO WHAT?
If you haven't read between the lines this far and clued the pieces together, this may be a potential buyout under the covers. Past Durata employees are familiar with what it takes to pass NDA / FDA approvals. Chief Scientist Michael Dunne has been developing this drug and trials since 2015, he also advocates that a NDA approval and distribution would cause this drug to have a EconomicMoat (Warren Buffet talks a lot about Economic Moat companies).
The potential here is after NDA and possibly prior to the FDA or PDUFA approval in Mar/Apr, this could have Pfizers eye along with a few large pharma companies. The current market cap of ITRM is around $100 million which is absolutely peanuts when compared to a blockbuster drug (500-1billion market cap). This could potentially mean a large buyout anywhere from $10-20 / share. However a fair warning, this is very speculative play but given the consensus of Durata previous staff now at ITRM, Pfizer drug that is in a market sector that has no new competitor in 20years, and Sarisa / Alex Denner eyeing for a ownership stake of ITRM, the sentiments are pointing to a positive influx of catalysts over the coming months.
This is a 1st mover advantage in a market that has traditionally been stagnant. My wife works in the medical field and a lot of the verbage is confusing, so I had her review Supolenum. Her findings were this is a fairly well received new drug and something that is much needed in the space. General UTI drugs have terrible side effects and cause intestine and gut bacteria which results in additional anti-biotics. Selopenum has similar side effects, however, much lower then the older products on the market.
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