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Did they ever move into the second cohort? I think it would be beneficial to see the outcome differences between dosing levels (or maybe no anticipated differences due to half life?).
I feel if IPIX was really bullish on partnering K, they wouldn't have reduced Menon's salary by 50%. Seems like a bearish move to me.
Yeah, but he's an expert on pre-revenue, startup biotech balance sheets. I don't know about you, but I invested for IPIX's balance sheet...... :)
How many times can one person say Preferred Shares?
We get it. We understand the risk. Most of us view the risk as minimal. Do you have any other positive or negative opinions about the company that might help add substance to the board?
You said .70 cents. .70 cents is 7/10's of one cent. Just like .70 dollars is 7/10's of one dollar (or 70 cents).
You said .70 cents. .70 cents is 7/10's of one cent. Just like .70 dollars is 7/10's of one dollar (or 70 cents).
How does one come to that conclusion if the drugs were abandoned? Wouldn't you need to know the drug's efficacy to make that conclusion?
.70 cents = $0.0070
Life lesson that can get you in trouble if you ever try to sell something less than a dollar.
A K update including enrollment status would be nice. I'm assuming we're still in the first cohort... hopefully they can speed this up a bit.
Maybe partner after first cohort and start another Ph2 for a different cancer or a combo study? I'm just somewhat impatient like most here and want to see efficacy numbers now lol.
$3/share by or before March...2018!
If you're going to have Severe OM for 10 days, but taking B just means you'll start having it tomorrow instead of today, is that really a benefit? This is why duration is important to me.
Thinking about this a little more...I guess a main benefit of delayed onset would be longer continuation of the cancer treatment though.
I'm not familiar with how data is received by the Company from clinical trials, but I would think that all of a patient's data would be submitted to them at the same time. If this is the case, I don't understand the time delay between reporting primary and secondary endpoints.
We aren't dealing with a large population, so I would think it wouldn't take long at all to get through the data. I would think one 8-hour workday with one person could insert all the data into whatever stats software they use, and another work day to analyze.
Anyone have insight into why there's a delay between primary and secondary endpoint reporting?
I understood it as the timeline was anticipated, not whether they were going to release data. I simple PR explaining why they were holding off on interim would have been sufficient for me.
Are we going to be blessed by one of your price predictions anytime soon? Maybe "Expect $10 by or before March 2018".
Or "Expect the share price to triple by or before 2018"
Still not sure what the difference is between "by" and "before".
Must be a really strong placebo pill.
Wow I missed that entirely...I must have been working too hard at work this week.
Thanks for the Gmail info.
Which shareholder email are you referring to? I'm looking through mine, but I've always struggled with searching through deleted Gmail emails...some old emails seem to never pop back up for me.
That's not acceptable. CEO stated in multiple PR's that interim data will be revealed. Hinting at no interim in a slide deck is not how a professional runs a company. I still expect interim data by the end of the month or a PR with an explanation as to why there will be no interim data.
In the broad scope of things, I wouldn't care about seeing interim data, but since the company stated we would have it, I expect to see it.
The company said we would get additional OM data at the conference that revealed final UP data, and that never happened. No explanation given either. I'm really hoping they don't repeat that mistake.
Why do people expect deals/partnerships/SP increase prior to these Phase 2 trials finishing up? The CDA's the company has been mentioning in PR's are about the results of the trials. To expect a deal prior to results is a little ridiculous, in my opinion.
Why would someone hold onto shares all through the beginning and middle of trials, then sell a couple of months before results? Why invest in a startup biotech if you're going to sell right before trials are finishing up??? I don't understand...
According to the Clinical Trials site, it looks as though the final four weeks are more to determine the total duration of severe OM (I believe for people on placebo and for B nonresponders).
In my opinion, these four weeks will help strengthen the trial results if the outcome showed patients treated with B had a duration of OM of 6 weeks, while placebo had 11+ weeks. If they cut the trial at 7 weeks, the difference between drug and placebo wouldn't be very convincing.
I'm expecting/hoping for much better results than that though!
It's an 11 week study. Four week follow up I believe.
If you were Dr. B and extremely bullish, wouldn't it make more financial sense to pay the taxes out of pocket and keep the shares? I don't really know what treasure stock is, so I might not be interpreting this correctly.
That would make sense. I guess doctors and patients would know the outcome of the results immediately since there's no blinding, and they could potentially be investors. Thanks for the input.
Any idea how the release of B-UP Cohort 3 results did not violate this? I believe they presented the results and issued the PR afterwards. Maybe I'm wrong???
That may be part of it, but that math doesn't add up. In the 200mg arm, 25% of ITT patients met the endpoint and 35% of PP patients met the endpoint. That does not match the 35% and 43.7% in the PR you posted.
My guess is because those OM patients had already finished the trial, IPIX was able to unblind which group they were in (I have no clinical trial experience, this is just a guess).
I'm assuming if we only see 6 week data from P, no one will have technically finished the trial at 6 weeks, so we can't unblind the data. If we get a mixture of data, then maybe we get some unblinded data from those who have finished???
This information is NOT true. The primary endpoint was met in 25% of all patients who received a dose of 200mg per day, not 35%.
In addition, the graph on the left on slide 12 in the link below can be misleading if not analyzed properly. From weeks 0 to 2, it looks as though IGA3 drops from 67.9% to about 53%. A big reason for that drop is because someone assigned to that group dropped out of the trial. They didn't actually have a reduction in disease, they left the trial so were no longer assigned to IGA3, which is why you see the drop in IGA3. This happens a couple of times throughout the graph. Just look at the percentages and do the math. Very misleading graph if you don't actually assign numbers to the percentages!
I still believe this trial showed hints of efficacy and I'm excited about the 2b results, but I think it's important for everyone to look at the RAW data, and not graphical interpretations of data with such small sample sizes with no explanation as to why the difference between ITT and PP.
https://static1.squarespace.com/static/5715352e20c647639137f992/t/583f7f14bebafbe20767391b/1480556310644/Prurisol-Presentation-for-Med-Derm-RD-Workshop_19Sep2016-u.pdf
In the 200mg PP population, it looks like 2 patients went from IGA3 to IGA2 and another 2 patients went from IGA3 to IGA1 between Weeks 2 and 4. The two point improvement in a two week time period seems impressive (granted, small sample size).
Another impressive jump occurs between weeks 6 and 8 when 1 patient went from IGA2 to IGA0 (if I'm interpreting the graph correctly and my math is right). I would like to see if any placebo patients had a two point improvement in a two week time period.
Notice how IGA3 levels off at week 6 though...hopefully increased dosage will improve that.
I'm hoping we partner up with K and start some combo trials next year. Imagine we have similar/better results to what they blogged about:
http://www.ipharminc.com/new-blog/2017/5/25/p53-gene-therapy-shows-added-efficacy-when-used-in-combination
"Laboratory studies conducted by Innovation and at leading institutions on the effects of Kevetrin in combination with approved cancer drugs, including studies against renal cancer, pancreatic cancer, ovarian cancer, glioblastoma and acute myeloid leukemia, have delivered promising data supporting the ability of Kevetrin to enhance chemosensitivity."
If you look at Weeks 2-4 on the ITT graph, you can see that IGA2 and IGA0 remained constant between those two weeks. This would mean some people jumped from IGA3 to IGA1 between Weeks 2-4. I would love to see this same graph for the Placebo group to see if anyone had that kind of jump so early in the study without taking P.
Very good point. Earlier today I had to go through the last 10 PR's to prove Leo doesn't try to pump the stock by mentioning "billions" over and over. I also got another read at the financials, which I haven't looked over in quite some time.
While going through the PR's, I noticed how much more professional they sound these days, even compared to the $2-3 per share days. We also have a much more professional website now too. The share price might be in the toilet, but I'm much happier with where the company is at on a clinical and professional level compared to when the stock was higher.
I don't know how you have the patience to counter all of these posters with facts, only to have them repeat themselves with the same misinformation over and over. I understand why you do it, but it must be frustrating.
I was not able to listen to the CC; however, is this the response you are referring to below? I can't imagine he said all of this in 15 seconds. Also, he once again reiterated that the goal is partnering and not diluting shareholders forever. If we have successful trials, no partner in 12 months, and Leo is diluting...then I can fully understand being upset.
From CC:
Leo Ehrlich
Okay. Well Cellceutix has always operated on low cash reserve. We've accomplished so much all the time, we just don't over dilute at any time. We try to be very conscientious of every share. We're concerned about the shareholders and dilution and perhaps that's the reason for the decline in our share price, but I think otherwise.
For most small price hikes, that is the nature of the beast; financing and money in the bank. If you look at the picture at the big picture, we've really accomplished a lot; successful clinical trial, we acquired another compound, we build a strong staff as 15 full-time employees without too much capital expenditures comparatively.
We've done this by operating really efficiently and we allocated our resources wisely. We remain flexible enough to adopt our cash burn as necessary as I mentioned our controlled cost of different trials. So therefore, we try to keep dilution at a minimum.
We still have millions of dollars available for our equity line and really our goal is we should accomplish several developmental milestones over the coming months. With strong clinical data, I wouldn't anticipate any difficulties in securing additional capital on favorable terms.
However, as we said, our goal is partnerships. If achieved that's game changing with respect to expeditious drug developments and infusions of capital. So, let's say ultimately, we're working vigilantly on maturing the negotiations towards landing a partner, but we're diligent on all the little capital needs that we always have to try to make sure there's enough in the bank to keep going. I hope that answers your question.
I also did a search for "$" in case they abbreviated "billions" with a "B" and used the dollar symbol. Interesting, the last time they used "$" in a PR was on 5/10, where Leo addressed the company's finances.
I just searched for the word "billion", and the last time he used that in a PR was on 4/3. There have been 9 PR's since then. Can you please provide evidence of Leo "using billions in every press release".
Also good to note, here is the "billion" reference on 4/3:
It is estimated that in 2016, in the United States, over 22,000 women will be diagnosed with ovarian cancer, with approximately 14,000 women dying from the disease. A $1.6 billion market, current treatment is often limited to surgery and chemotherapy and there is no cure.
I was googling around and this old post that I'm replying to came up (#120460). Definitely worth another read as we wait for interim results.
Otezla pre-clinical mouse study - I believe this is it:
http://onlinelibrary.wiley.com/doi/10.1111/j.1476-5381.2009.00559.x/full
Quotes from Discussion Section:
"Notably, four of seven (57%) grafts from the apremilast-treated mice underwent a partial or complete recovery of histological features; whereas, three of seven grafts from cyclosporine-treated group displayed a histological recovery."
"Together, these data suggest that the human skin xenotransplant SCID mouse model may serve as a tool for investigating potential agents directed against the pathophysiological mechanisms of psoriasis. The anti-inflammatory activity of apremilast, as demonstrated in vitro and in a preclinical psoriasis model, has translated into clinical efficacy in this disease."
IPIX Press Release Quote (12/19/2016):
In laboratory studies, Prurisol was found to be effective against psoriasis in animal models, both in induced psoriasis and in a xenograft model using human psoriatic tissue. In these models, Prurisol eliminated virtually all signs of psoriasis.
Assuming we partner and have enough funds to support multiple trials next year, what do you guys think our 2018 goals are?
1. P - initiate Ph3
2. B-OM - breakthrough, initiate Ph3
3. B-ABBSSI - initiate Ph3
4. B-UP - develop foam/gel, develop pill for upper GI, Ph2b
5. K - Ph1 for pill, Ph2b ovarian combo therapy
Where did the pre-clinical info go? I can't seem to find it on their new website.
I think I remember someone on here showing a good relationship between their pre-clinical process results and potential clinical results (likely from studies on other psoriasis drugs). I'd like to look into that again, but I can't find it!