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.
Not that it matters as we'll get results soon, one could argue the trial variables were stricter and more challenging than Otezla.
Let's say it's 13 people vs 6 placebo. Keep in mind subjects had mild psoriasis, so not surprising placebo is higher....Should be lower in P2B. On flip side, based on stratified data since P2B has moderate / severe psoriasis the # of people with success should be higher. So spread widens.
So, they ran P2a in case there were unrealistic results. They then decided to run P2b even though the P2a results were not at near perfect efficacy. Why run P2b then?
Then why run the trial?
Today seemed to be a pestimistic day on this board from many, including some pro IPIX people. Must be that it's about time for news update.
At least the company has a development plan for B OM. Per PR...“CoreRx is now a valued contributor to advancing our Brilacidin development plan.”
I just don't subscribe to the logic that Leo is duping investors by knowing results of P and not telling us because it failed primary endpoint. Or that he's dragging us along to milk his salary and lifestyle.
Then why set up as milestones? Why drag it out if not close to partnering? I know, so he can live a lavish lifestyle a couple of months longer (per some posters' logic).
Why spend money on P2B if not an outstanding chance for success or not communicate if he had a glimpse much earlier that trial wasn't successful? Or not communicate even now?
Submitting a BTD application without background due deligence and questioning FDA what it would take to get it? I don't think so. May not get it since so few companies achieve it. But why sign contracts with manufacturers? Right...to mislead investors and drag it out.
Why do some continue to post here then?
Halelujah...where's my coffee?
Maybe you have been feeling this way for a couple of months?
You should wait until after P results announced and signed partnership, no?
B is a synthetic, non-peptidic small molecule
Round and round we go..comments without support. 2 people? 2 only?
Powered.
P2b was designed that way because of what was seen in P2a. Spend money when reasonably confident that results will be positive. It's Leo's approach.
Still waiting for what it means to fail. not different from placebo statistically? Not meeting otezla at same trial point?
By fail I assume you mean the primary outcome of PASI scoring? If so, what does failure look like? 20% above 75? 30%? Higher?
Good question and worth debating. Why did he seek the funding that he got?
Then you should buy as many shares as possible...to basically double your money.
Do you think short half life may play a part in a P3 should P2B be successful? Wondering if they may attempt 3 dosings per day.
Meant something to Dr B, who is a professional in his field. Meant enough to spend more money on it. My comments are based on facts from the company; your's is simply based on gut feel.
Company also commented...
Cellceutix is extremely proud of the Phase 2 Prurisol results. Simply put, the drug’s efficacy compares favorably with many current and various types of treatments for psoriasis (see the study linked to below), including apremilast or Otezla®, which is the leading oral FDA approved anti-psoriasis drug. It is interesting to do a side-by-side comparison between the two based on publicly available literature, and it could be argued that Prurisol performs on par with, if not better than, Otezla® at the identical stage of development
Right. Ok. Nonsense.
The statement below is from a May 26 PR:
Additional preliminary data analyses of secondary endpoints show patients who received any dose of Prurisol, regardless of the treatment arm, had a 1-point improvement (using the IGA scoring system) at a higher rate than that of patients in the placebo arm. This is another clear indication of the drug’s efficacy.
Makes no sense. It's psoriasis. Also, you say 90% would mean something, but at the same time you allude to a small samole size. Study was not powered for stats. And all patients responded to P.
Then what was the purpose of 2a. I mean why would they do it if they knew the %s would be meaningless?
In your opinion, why does BP not want the drugs?
BooDog, because of my being new to biotech, how do you think it will unfold if P is successful? Guess I'm wondering about volume. My gut feel is a buyout will happen, but I'm guessing that route because I have not seen growth leading to uplisting for a company.
Beginning to think there are only a handful of long term shareholders on this board. The rest seem to be short term flippers, either positive or negative. I think maybe 5 that have over 200k shares that are not flipping. Hard for me to tell who's doing what at times.
From what I'm reading on this board, I'm understanding the price has been dropping because people think BTD was rejected, P failed,and there is no potential partner?
I just can't figure out why Mgt would want to delay communication then.
It's August. If the above were true, then nothing is going to change by September.
Is it possible they are in final steps of a deal, P results are not known yet..or at least not yet compiled enough to communicate, and BTD is still open pending final response?
Then maybe Otezla barely squeezed by?
The ph2a was not designed to have stellar results or to sail by placebo or competition. It was designed to be a challenging trial under extreme conditions, even included those previously unsuccessful in biologics likely to see if the money was worth spending on further development. My guess they wanted to spend on B and K but found P was worth the $ allocation. Turns out signs were that it was worth it. Guses we'll see soon, probably by end of August I would think.
Understood.
The study’s main goal was to provide indications of efficacy, safety and tolerability upon treating patients with mild to moderate plaque psoriasis via oral delivery, per the company.
You're mentioning knockout product.
And you mention P was not impressive at all vs placebo.
The company did not intend the to show knockout results. I believe they are trying to prove a pill form of psoriasis treatment that can work earlier and be safer. Not going for homerun. Per company, patients who received any dose of Prurisol, regardless of the treatment arm, had a 1-point improvement (using the IGA scoring system) at a higher rate than that of patients in the placebo arm. This is another clear indication of the drug’s efficacy.
It's my understanding P2a was not designed for stats significance. I also understand it was designed with high bar hurdles. Even with this, 200mg showed signs of efficacy and on par with Otezla in some ways. So, low dosage and yet still achieved that combined with strong positive clinical testing. More signs point to good enough sucess vs failure in my opinion. I understand the points you have made in the past, but I think signs point to more optimizism than less.
Not sure that's how the agreement was designed. I believe the intention was to spreadout. To me it means BTD first.
But we know P2b is different than P2a in many positive ways, which have been outlined already.
Karin, with my being new to biotech, I must admit I'm having trouble waiting and enduring the poor price behavior. Just struggling a bit on what could be holding things up on B.
BTD list is short...at least CY2018. Impressive names.
“We believe the Company has a significant chance to achieve each of these milestones.”
From the PR announcement
Right. Thanks, KFC. Should be an interesting filing.
Not before 10q?
Feels like PR coming within 5 business days. My guess is BTD for B OM.
PlentyParanoid, not sure I follow your statistics. Can you define what Failure would look like on P2B?
Pete, likely due to mild psoriasis?
Not sure where you're coming from. You think Leo is fooling BPs and Shareholders by manipulating data?
Why wouldn't Aspire want IPIX to meet the milestones?
And? Not sure I follow your point.
Why didn't Leo loan money? Maybe he can at last resort.
The recent agreement PR causes me to think Aspire is buying or not selling as much and with intent to buy soon. Maybe this explains recent support.
Also, they will buy at each milestone meaning price could escalate at EACH milestone thus driving up price further each time. Per PR, "Each of the milestone payments will be made at a purchase price based on the five-day average of the closing prices of Company’s common stock at the time of each announcement without any discount to such five-day average."