Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Liv sold but McNally didn't!
thinks...
https://www.obseva.com/wp-content/uploads/2022/03/ObsEva-Annual-Report-2021.pdf
Looking forward to 2022:
Thanks to the significant progress last year, we enter 2022 stronger and well-positioned for anticipated approvals. Looking ahead, we expect multiple catalysts, including:
? Yselty® for uterine fibroids:
– PUDFA target action date of September 13, 2022, as set by the FDA
– European Commission approval expected following December 2021 positive CHMP opinion
– Preparing for commercial launch
? Yselty® for endometriosis:
– Additional data from the post-treatment follow-up of the Phase 3 EDELWEISS 3 trial are
expected in 2Q 2022 and from the post-treatment follow-up of the extension study in 4Q 2022
? Ebopiprant:
– Discussing US clinical development with the FDA
? New opportunities:
– Exploring new indications, partnerships, and other strategic opportunities that enhance
ObsEva’s value and further our mission of bringing to market novel therapies that improve women’s health
? Financing: Furthering ongoing efforts to strengthen the balance sheet
They burn so much money that it looks like a paper mill ... lawful scam on a large scale!
Will the sales be real?
beautiful soul who eliminated my message because vulgar: So is it okay?
FTS
I'm sorry for all the bulls here!
I fell into the trap of the shorts!!
I didn't want to enter but I saw a lot of passion in shorttwits.com... I have to say that I feel lucky, lately I had lost some motivation in FTS!
Today I am full of energy!
Revenge is needed!
But here they won it must be admitted! Well, there is a place that sizzles... many of you know it!
We are waiting for a nice short squeeze! Get revenge! Maybe it was better that you weren't out of CTIC, don't you think!
FTS
Ouch!
at this point luckily to have few!
I went in for that!
however I like the halt!
I have an idea this is going to be epic!
too bad to have a few!
halted! fingers crossed!
what great sons of good women! why wait?
I got a handful now!
Nobody should know!
03/15/2022 8,316,332 19,273,272 1
02/28/2022 6,634,484 1,659,793 3.997176
02/15/2022 6,330,335 870,251 7.274148
01/31/2022 5,081,535 1,559,251 3.258959
01/14/2022 2,549,192 1,351,533 1.886149
12/31/2021 2,989,143 1,381,568 2.163587
Tic toc tic toc
ReniBenjamin
Okay. And then I guess just turning to the commercialization side. Can you just remind me, have you guys already identified the centers or the community docs that you will be targeting right off the bat? Or how should we be thinking about the initial phases of the launch?
AdamCraig
Bruce will answer.
BruceSeeley
The -- in initial launch were not surprising any target, the high volume accounts in the academic centers, and then we've identified also the large community accounts that treat quite a few patients, the group practice or the large group practices. And that's where the far majority of the patients are treated.
ReniBenjamin
And Bruce, about how many, could you give us like how many accounts are there from academic versus community?
BruceSeeley
It depends on how you look at it. Just in terms of number of physicians, the majority of physicians are going to be in the community accounts. They treat anywhere from 0, 1 or 2 patients to 5-ish patients. The large practices are the ones that we're going to be focused on. And the academic centers we're focused on, they can treat 20 to 50 patients per year depending on the site.
Operator
Your next question is from Thomas Flaten of Lake Street Capital.
ThomasFlaten
Adam, how do you -- how should we think about PACIFICA enrollment once you guys go live commercially? Do you see there being some cannibalization there or have you -- do you have a strategy for segregating patients in the study versus commercial product?
AdamCraig
Thank you. Its a very important question. The - its most likely that PACIFICA will continue ex-U.S. after approval. And we are no doubt towards the end of the NDA process where we'll have some discussions with the FDA around the program -- around that trial with maybe some changes to it. But big picture, I don't expect that to be cannibalization of U.S. sales opportunities. The drug is performing very well ex-U.S. at the moment, and I think we could successfully complete the trial outside the U.S. on time.
ah how I feel all sore!
Big headache, very high fever! Think if I was not vaccinated!
Heavy the "coviddi"!
I can't even focus what I see ... let's break through 1.54!
In my family they are all positive!
I stay out but I feel broken bones and shivering! Maybe soon it will be my turn too: I am fully vaccinated, so don't worry!
In a month there will be intensive care full of unvaccinated!
natural selection!
Residues of Neanderthal homo still remain and they are probably shorts here!
LOL
the withdrawal of Russian troops from the Ukrainian capital has begun!
It seems that the thaw has begun in every sense!
Good!
I would feel bad being a shorts here!
For real!
Do you know why the price of gas has gone up so much? Only for speculators who had bet on the downside!
CTIC is a bonbon!
For example pfizer is full of money!
CLLS ALLO...
Cancer Drug... Allo-SCT... GVHD...
Golden Cross
Robocop
So, let me think!
Does the funds sling inside? Or does we fall?
We have an endorsement that Robocop (and if he says so I would not underestimate it) says it will bring us 3 bil in 2026!
Then there is the GVHD speech!
In a while we will have a taste of sales...
In June Russel
In September, or thereabouts, we'll know more about the bomb... I mean allo-SCT
And in the meantime the sales to go up...IMO
I hold ya
what a beauty!
NEW HIT
https://clinicaltrials.gov/ct2/show/NCT03645824?cond=Pacritinib&draw=2&rank=8
Despite recent new therapeutic options, allogeneic Stem Cell Transplantation remains the only curative option in patients with Myelofibrosis. Therefore, optimalization of this therapy remains a major challenge. Improvement of the clinical condition of these patients, decreasing spleen size can be accomplished by JAK2 inhibitor treatment and might improve SCT outcome. In addition, selective JAK2 inhibitors might modulate GvHD which can also add to improved SCT outcome. Also, decreasing the burden/activity of the disease before allo-SCT might also improve final disease response. The first, limited, clinical data of ruxolitinib treatment before allo-SCT show controversial effects on the outcome of SCT. Therefore, additional prospective clinical trials have to be done to establish the role of JAK2 inhibition before allogeneic SCT. Since ruxolitinib has considerable myelosuppressive effects which might limit the clinical use in some MF patients, other selective JAK2 inhibitors might be useful in this setting. Pacritinib, as a JAK2/FLT3 inhibitor, has a very potent JAK2 inhibitory activity without myelosuppressive effects and might therefore be more suitable than ruxolitinib. The major possible side effects are gastro-intestinal and can be managed with medication. In several studies, pacritinib has shown to be effective in decreasing spleen size and has shown to improve clinical condition of patients. Therefore, this compound seems promising in improving the outcome of allo-SCT. Although pacritinib causes no inhibition of JAK1 activity and therefore might have limited effects in decreasing inflammatory response, this might also be of benefit since a "withdrawal syndrome" as has been described after cessation of ruxolitinib is not to be expected.
Elizabeth Garner, MD, MPH, Chief Medical Officer of ObsEva, commented, "We are pleased with these additional EDELWEISS study results, which demonstrate the rapid onset of treatment effect, impact on quality of life and intentions for surgery, and continue to support the promising clinical profile of linzagolix in the treatment of women with moderate-to-severe endometriosis-associated pain. We look forward to advancing the endometriosis program for linzagolix, which will include exploration of a non-add back therapy option, consistent with our strategy to address the individual treatment needs and preferences of all women."
I remember 20
Here it says 35!
https://clinicaltrials.gov/ct2/show/NCT03762655?cond=Neuro-Spinal+Scaffold&draw=1&rank=2
Could they have changed the number?
IMO Soon
Submit De Novo Application to FDA and Anticipated Marketing Clearance
Hell will end when the new CEO appears ...
We deserve a good one!
Otherwise better Paul Cat
Well in short, if this is no longer delisted, it will hurt so much to the shorts
Come on give us fireworks!!!!
Pump it!
Not only must we guide the development of China-US relations on the right path, but we must also assume our due international responsibilities to make efforts for world peace and tranquility ... says Xi
I hope they throw kisses at the end of the call!
I wouldn't be surprised by a takeover here!
MC 400/450 mill are peanuts
Carpe diem!
Scott has earned leadership on the field!
Now it is clear why they put him in charge!
Ridiculous MC
between assets and cash it should quote double!
Shoooortyyyyyyyyyyy !!!!!
A little sorry for you!
But you still have time to contain the damage!
Think covering 7 as it could be!
Shoooortyyyyyyyyyyy !!!!!
A little sorry for you!
But you still have time to contain the damage!
Think covering 7 as it could be!
Come on, it seems that peace is coming ... Covid mutations start again ...
it looks bad for the shorts!
Paytience!
waiting for sales ...
Paytience!
waiting for sales ...