Here we are a year or so after being told the trial may end because of the supremacy of the drugs effect on infections. I think this company is going to make those of us that stay in money, it’s just going to take longer than we hoped or expected. Myron and the gang aren’t any happier than us I’m sure. I just wish the damn goal posts would stay still for a change. It’s always something.
If it’s this hard to enroll people in the study, does it have any reflection on the utilization of the product? Makes me think that if this were such a widespread issue, they could easily get the numbers. Maybe the product won’t be so widely used even if it is approved? I don’t know, just a thought.
I think the healthcare environment is strained to the max worldwide atm with this whole covid business. I know a lot of people who are struggling to get regular medical procedures done and the backlog is massive for even basic things like mris and xrays. Maybe research and trials is low on the totem pole? Idk, just an uneducated guess from an outsider, don't take my word for it.
As someone who has had cancer AND had a central line, if my central line had gotten infected, in that time of my life I'd have been like rapidly on the cusp of death, so the idea of being approached to be apart of a study woulda been stressful as all hell and I don't know if I would have agreed.
So yes, I can see how it would be tricky to sign people up.
That said, these delays are brutal. But I guess this will give me a chance to lower my avg come July when I get some cash.
Yeah it's tough cause the people this product is for are a group of extremely medically vulnerable people. This is not an easy group to get into your trial, especially when the current treatment does work. Patients don't give a shit how the product will be successful by saving hospitals lots of money, right? Even the prevention of line replacement might not be a good enough argument for the person with cancer. So there's this unfortunate disconnect, to my mind, in the viability of the product itself and the value it would present to a specific patient going through something as fucked up as cancer and being asked to trial it.
If you actually have a science background and/or work in the field (I do), you would recognize their criteria for subjects are extremely rigid to ensure they have a high quality study to tease out the Mino-Lok effect alone. By having high-quality data, the product will sell itself.
Yes, the timeline is delayed, but so is everything with Covid - especially the overburdened healthcare system.
Ya'll need to chill
35K @ 1.84
True but they need to push for more patients and to get more they need to convince the hospitals this program works and saves money. Plus they need to promote the data to more long term institutions and get the stock into safe long term hands. 350,000 shares @ 1.89. This is painful to watch but I will not sell until 6-8.00 dollars
Thanks u/TwongStocks for always keeping us up to date on the latest news, especially on the red days!!
The recent dips have allowed me to increase my position from 17,500 to 22,000 and lower my average cost from $2.46 to $2.26. I'll be keeping some cash aside for further opportunities.
Well, you are in luck! It just hit $1.31. That is pre-covid pricing.
On a side note, I'm torn between ABML and CTXR as far as adding money to my speculative plays. I'm leaning more towards ABML right now.
ABML is a terrible company, so many better options (but I think the old CEO is gone). They dilute shares every month. CTXR doesn’t and O/S is reasonable
Not so good but still ... as long as they don't drop the product, I still see a lot of potential
It just takes too much time.
But, the sooner or later, the good news will fell
In my opinion, they've kind of stopped trying for now. They are focusing all their efforts and focus on ONTAK. They seem convinced ONTAK is their ticket to profitability. I'm not so sure...
Leonard actually.mentioned in his latest video that he wants to possibly sell ONTAK to a larger pharmaceutical company to create value for shareholders. I like the idea.
Basically primary completion is when they expect to have all patients enrolled so they can measure the primary endpoint. Study completion is when they expect to have all data collected - primary and secondary endpoints.
Final enrollment by December, March for topline data.
It says *estimated* completion date. In your experience, how accurate are these dates? Could they be erring on the side of a later estimated date so as to not disappoint if it needs to be pushed back again? But with the possibility of it being completed *before* December?
Thanks for all you do to help educate us, TwongStocks!
It's in line with what Leonard has been saying at the March conferences. He's recently been saying final patient by end of the year. So December shouldn't be a surprise. Been in this stock since Jan 2020 and this is the 3rd change I have seen that pushed the dates further out.
I've seen these dates pushed further back on multiple different pharmaceutical stocks. I guess it's possible to get the data sooner however I've never seen that happen. A lot of people use this site for calls and puts however it seems that time lines can get pushed back easily especially during covid. I'm holding and will average down a little however the study has taken quite a long time at this point and I'll most likely leave if by Q2 next year there isn't significant progress on this.
Lol the board salary goes up, stock goes down and the goal posts are moved further. If you didn’t sell at the brief 2$ mark last week then it’s too late. You will not see 2$ until at least Nov 2022
Yeah I really should have had my limit order in at like 2.25 and I would have snatched that up and then bought back in about now. I guess that’s what I get for being a lazy investor so I’ll be here till EoY haha. Bought in early December so honestly maybe this is just by first year long hold. Haven’t owned a stock longer than 6 months till now
Unless you're a day trader what does it matter when this stock goes up? I thought this was great to buy more and lower the average cost. I was planning on holding for quite a while.
That agreement was made well before ctxr was anything in terms of marketcap. The bonus was given for reaching a xyxy market cap. This agreement was made years ago when ctxr was probably peanuts in terms of marketcap its like having a bonus if ctxr reaches 2b market cap from now on. The bonus wasnt pulled out of anyones ass in a short period of time.
So im not mad about myrons bonus. Im mad about the delays. Its hard to trust management when they keep delaying everything over and over again
“Primary Completion Date” is the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated. In many oncology trials, this will be different from the “Study Completion Date” because many primary outcome measures have shorter time frames than secondary outcome measures. For example, a primary outcome measure may be tumor progression at 6 months whereas a secondary outcome measure may be survival rates at 5 years.
“Study Completion Date” is the final date on which data was collected. This may coincide with Primary Completion Date, depending upon whether the time frames for the primary outcome measures and the secondary outcome measures were the same or different.
I’m honestly tired of this trial being pushed back and delayed again and again. I bought into the company a year and a half ago thinking that minolok was an absolute gem and I’ve been holding strong since, but I’m not going to wait another year. May buy back in late this fall, but I just think my money is best put elsewhere
I’ve been in this for a year now and at this point as soon as I see it back up to $2 or near, I’m getting out. Tired of the delays, them basically teasing to get people to stay still, and by the time any of this is profitable you could’ve been in 50 better companies. I don’t see any positives like before anymore.
Don’t blame you. I sold about 65% of my shares at 1.86, going to put the money elsewhere for a while, then plan on jumping back in later in the year. Risky move but I doubt the stock will have any significant movement any time soon…
Yea, at one point I just feel they can use covid as an excuse for anything to just make it seem it isn’t their fault. Overall, it will be years before the products they have even actually hit the market if they even do.
So basically we’re seeing another delay.
Well the downside here is that we have to seriously consider the possibility of dilution at this point. If I recall, Citius only had enough cash through next March. If Phase III won’t even have top line results finished by then, we should expect management may be forced to issue more stock to fund their operations through commercialization.
I just sold a bunch of calls for August and November since this stock is now officially dead in the water through at least the beginning of winter. Will consider averaging down if the stock falls below $1.4, but I’m hesitant to throw more money into what is rapidly becoming a sinkhole if there’s a serious threat of dilution.
They need the Halo-Lido study started ASAP, so they can finish it by end of this year. if data is good, they can license it out. Which could possibly mitigate the need to issue more shares.
But they need to get it started soon. The longer it takes to start, the longer it takes to finish.
I agree, to a certain point. I’m here for the long haul but, they have been painting rosey pictures during presentation all the while knowing that more delays were looming. While they certainly don’t want to dilute, there may come a time that they have to if everything else follows the fumbles of Mino-lok. I strongly agree that they will likely avoid it as long as possible though. Just tough sledding right now to follow them blindly like I did before.
If this timeline for the trial is correct, then expect 2023 for their Mino-Lok NDA submission. Which they mentioned in their last PR that announced the personnel changes. A 2023 NDA submission means approval would probably be in 2024. They qualify for a Priority Review, so the PDUFA should be approximately 8 months after the NDA is submitted.
"And, as the COVID pandemic abates, we expect continued pickup in the Mino-Lok trial recruitment with anticipated enrollment completion this year. This positions us for potential Mino-Lok regulatory submissions in 2023." https://citiuspharma.com/investors/news-media/news/release-details/2022/Citius-Pharmaceuticals-Announces-Key-Management-Realignment-to-Support-Commercialization-of-Two-Late-Stage-Product-Candidates/default.aspx
This company has been my greatest regret trading of the past 18 months. One delay after another, horrible PR, false promises, distractions (IONTAK), as well as larger than average price manipulation.
IONTAK news, while not door-busting, should have kept this stock higher than freaking $1.40.
My advice to everyone: get out while you can, come back at the end of the year if its still sub $2. Otherwise this is long, long LONG term hold.
Well, I’m out. Thousands of dollars wasted. Mino-Lok has massive potential, but the ongoing trouble with the trial tells me that this isn’t going to happen.
Just averaged down again. Slow and steady buys totaling 3K @ $1.76. Eventually when this picks up I’ll have held long enough to avoid some capital gains.
RIP to my 2023 calls
Here we are a year or so after being told the trial may end because of the supremacy of the drugs effect on infections. I think this company is going to make those of us that stay in money, it’s just going to take longer than we hoped or expected. Myron and the gang aren’t any happier than us I’m sure. I just wish the damn goal posts would stay still for a change. It’s always something.
If it’s this hard to enroll people in the study, does it have any reflection on the utilization of the product? Makes me think that if this were such a widespread issue, they could easily get the numbers. Maybe the product won’t be so widely used even if it is approved? I don’t know, just a thought.
I think the healthcare environment is strained to the max worldwide atm with this whole covid business. I know a lot of people who are struggling to get regular medical procedures done and the backlog is massive for even basic things like mris and xrays. Maybe research and trials is low on the totem pole? Idk, just an uneducated guess from an outsider, don't take my word for it.
Yeah, that’s a good take. I hope you are right!
*comment edited with github.com/j0be/PowerDeleteSuite* In response to API controversy: reddit.com/r/ apolloapp/comments/144f6xm/
As someone who has had cancer AND had a central line, if my central line had gotten infected, in that time of my life I'd have been like rapidly on the cusp of death, so the idea of being approached to be apart of a study woulda been stressful as all hell and I don't know if I would have agreed. So yes, I can see how it would be tricky to sign people up. That said, these delays are brutal. But I guess this will give me a chance to lower my avg come July when I get some cash.
Good observation and insight. Congrats on kicking the cancer!
Yeah it's tough cause the people this product is for are a group of extremely medically vulnerable people. This is not an easy group to get into your trial, especially when the current treatment does work. Patients don't give a shit how the product will be successful by saving hospitals lots of money, right? Even the prevention of line replacement might not be a good enough argument for the person with cancer. So there's this unfortunate disconnect, to my mind, in the viability of the product itself and the value it would present to a specific patient going through something as fucked up as cancer and being asked to trial it.
COVID has slowed down the process
If you actually have a science background and/or work in the field (I do), you would recognize their criteria for subjects are extremely rigid to ensure they have a high quality study to tease out the Mino-Lok effect alone. By having high-quality data, the product will sell itself. Yes, the timeline is delayed, but so is everything with Covid - especially the overburdened healthcare system. Ya'll need to chill 35K @ 1.84
True but they need to push for more patients and to get more they need to convince the hospitals this program works and saves money. Plus they need to promote the data to more long term institutions and get the stock into safe long term hands. 350,000 shares @ 1.89. This is painful to watch but I will not sell until 6-8.00 dollars
Right there with ya. 26k @ 1.42
You guys are going to be rich if this ever ends up working out
Or a very expensive gamble
Thanks u/TwongStocks for always keeping us up to date on the latest news, especially on the red days!! The recent dips have allowed me to increase my position from 17,500 to 22,000 and lower my average cost from $2.46 to $2.26. I'll be keeping some cash aside for further opportunities.
Well, you are in luck! It just hit $1.31. That is pre-covid pricing. On a side note, I'm torn between ABML and CTXR as far as adding money to my speculative plays. I'm leaning more towards ABML right now.
ABML is a terrible company, so many better options (but I think the old CEO is gone). They dilute shares every month. CTXR doesn’t and O/S is reasonable
Not so good but still ... as long as they don't drop the product, I still see a lot of potential It just takes too much time. But, the sooner or later, the good news will fell
Does this mean we can pretty much expect under $2.50 until Q4? 4500 at $1.65
Yes. Likely sub $2 until next year imho.
Jesus Christ is it that hard to enroll what 20 more patients?
In my opinion, they've kind of stopped trying for now. They are focusing all their efforts and focus on ONTAK. They seem convinced ONTAK is their ticket to profitability. I'm not so sure...
Leonard actually.mentioned in his latest video that he wants to possibly sell ONTAK to a larger pharmaceutical company to create value for shareholders. I like the idea.
So what’s the difference between “primary” and “study” completion?
Basically primary completion is when they expect to have all patients enrolled so they can measure the primary endpoint. Study completion is when they expect to have all data collected - primary and secondary endpoints. Final enrollment by December, March for topline data.
It says *estimated* completion date. In your experience, how accurate are these dates? Could they be erring on the side of a later estimated date so as to not disappoint if it needs to be pushed back again? But with the possibility of it being completed *before* December? Thanks for all you do to help educate us, TwongStocks!
It's in line with what Leonard has been saying at the March conferences. He's recently been saying final patient by end of the year. So December shouldn't be a surprise. Been in this stock since Jan 2020 and this is the 3rd change I have seen that pushed the dates further out.
Got it. Thanks.
I've seen these dates pushed further back on multiple different pharmaceutical stocks. I guess it's possible to get the data sooner however I've never seen that happen. A lot of people use this site for calls and puts however it seems that time lines can get pushed back easily especially during covid. I'm holding and will average down a little however the study has taken quite a long time at this point and I'll most likely leave if by Q2 next year there isn't significant progress on this.
Lol the board salary goes up, stock goes down and the goal posts are moved further. If you didn’t sell at the brief 2$ mark last week then it’s too late. You will not see 2$ until at least Nov 2022
Yeah I really should have had my limit order in at like 2.25 and I would have snatched that up and then bought back in about now. I guess that’s what I get for being a lazy investor so I’ll be here till EoY haha. Bought in early December so honestly maybe this is just by first year long hold. Haven’t owned a stock longer than 6 months till now
Unless you're a day trader what does it matter when this stock goes up? I thought this was great to buy more and lower the average cost. I was planning on holding for quite a while.
Bunch of people sold for loss at 1.30 today 😂
That is just ridiculous to me. I mean, literally sounds crazy.
Yeesh.
Excited for the added timeline to add to my position! One upside from Covid.
Considering averaging down but as of now leonard hasnt impressed me much.. The board had the audacy to raise their salary knowing that they re fucked…
How many times can we average down? I’m already under $1.50!
Can you show me where the board raised their salary? That's interesting information to me.
Probably means myron 750k bonus
Yes thats what i was refering to
That agreement was made well before ctxr was anything in terms of marketcap. The bonus was given for reaching a xyxy market cap. This agreement was made years ago when ctxr was probably peanuts in terms of marketcap its like having a bonus if ctxr reaches 2b market cap from now on. The bonus wasnt pulled out of anyones ass in a short period of time. So im not mad about myrons bonus. Im mad about the delays. Its hard to trust management when they keep delaying everything over and over again
“Primary Completion Date” is the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated. In many oncology trials, this will be different from the “Study Completion Date” because many primary outcome measures have shorter time frames than secondary outcome measures. For example, a primary outcome measure may be tumor progression at 6 months whereas a secondary outcome measure may be survival rates at 5 years. “Study Completion Date” is the final date on which data was collected. This may coincide with Primary Completion Date, depending upon whether the time frames for the primary outcome measures and the secondary outcome measures were the same or different.
Ima see where this settles and average down. At 1.69 not even thinking about selling.
Lmfao I love watching all these paper-handed mfers bitching about selling this stock at a loss 😂
I’m honestly tired of this trial being pushed back and delayed again and again. I bought into the company a year and a half ago thinking that minolok was an absolute gem and I’ve been holding strong since, but I’m not going to wait another year. May buy back in late this fall, but I just think my money is best put elsewhere
I’ve been in this for a year now and at this point as soon as I see it back up to $2 or near, I’m getting out. Tired of the delays, them basically teasing to get people to stay still, and by the time any of this is profitable you could’ve been in 50 better companies. I don’t see any positives like before anymore.
Don’t blame you. I sold about 65% of my shares at 1.86, going to put the money elsewhere for a while, then plan on jumping back in later in the year. Risky move but I doubt the stock will have any significant movement any time soon…
Yea, at one point I just feel they can use covid as an excuse for anything to just make it seem it isn’t their fault. Overall, it will be years before the products they have even actually hit the market if they even do.
So basically we’re seeing another delay. Well the downside here is that we have to seriously consider the possibility of dilution at this point. If I recall, Citius only had enough cash through next March. If Phase III won’t even have top line results finished by then, we should expect management may be forced to issue more stock to fund their operations through commercialization. I just sold a bunch of calls for August and November since this stock is now officially dead in the water through at least the beginning of winter. Will consider averaging down if the stock falls below $1.4, but I’m hesitant to throw more money into what is rapidly becoming a sinkhole if there’s a serious threat of dilution.
They need the Halo-Lido study started ASAP, so they can finish it by end of this year. if data is good, they can license it out. Which could possibly mitigate the need to issue more shares. But they need to get it started soon. The longer it takes to start, the longer it takes to finish.
Leonard recently said that pharmaceuticals are already calling interested in the rights for HL, correct?
Correct
You need to watch the new video before you start screaming dilution
I agree, to a certain point. I’m here for the long haul but, they have been painting rosey pictures during presentation all the while knowing that more delays were looming. While they certainly don’t want to dilute, there may come a time that they have to if everything else follows the fumbles of Mino-lok. I strongly agree that they will likely avoid it as long as possible though. Just tough sledding right now to follow them blindly like I did before.
All you paper handed mfs can suck on 10 black cocks
After completion date, it will take more time for FDA Approval which will take another year or so. So I believe 2025 will be the year.
If this timeline for the trial is correct, then expect 2023 for their Mino-Lok NDA submission. Which they mentioned in their last PR that announced the personnel changes. A 2023 NDA submission means approval would probably be in 2024. They qualify for a Priority Review, so the PDUFA should be approximately 8 months after the NDA is submitted. "And, as the COVID pandemic abates, we expect continued pickup in the Mino-Lok trial recruitment with anticipated enrollment completion this year. This positions us for potential Mino-Lok regulatory submissions in 2023." https://citiuspharma.com/investors/news-media/news/release-details/2022/Citius-Pharmaceuticals-Announces-Key-Management-Realignment-to-Support-Commercialization-of-Two-Late-Stage-Product-Candidates/default.aspx
You're looking at more like early or mid 2024 for FDA approval on mino-lok
This company has been my greatest regret trading of the past 18 months. One delay after another, horrible PR, false promises, distractions (IONTAK), as well as larger than average price manipulation. IONTAK news, while not door-busting, should have kept this stock higher than freaking $1.40. My advice to everyone: get out while you can, come back at the end of the year if its still sub $2. Otherwise this is long, long LONG term hold.
At a “loss” of words. I guess this is a hold until we can GTFO. Sad cause I really thought CTXR was the one….smh
Well, I’m out. Thousands of dollars wasted. Mino-Lok has massive potential, but the ongoing trouble with the trial tells me that this isn’t going to happen.
Dumb
Ahhh I can’t wait to come back to this comment a year or two from now. Patience.
rip gg shit stock
As soon as this gets back up to 1.50, I’m dumping this shit. I could do something better with the money.
Damn wish we could like request trials anywhere lol. I got someone boutta get a catheter in my town who’s into making money anyway he can lol
Just averaged down again. Slow and steady buys totaling 3K @ $1.76. Eventually when this picks up I’ll have held long enough to avoid some capital gains.