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There is a show and conference on January 8. It’s an obvious time to release new data.
Oh, bullshit. Management hasn’t done a large capital raise during the entire life of the company. Why would they do it now?
Further, why would there be a drop off from the earlier data release? The drop off for the spread between placebo and B-OM groups is easily explained by the higher adverse events in the placebo group and dropouts mostly coming from >= grade 3 OM of that placebo group. Evidence of that is 1) the almost 100% increase in less severe OM over historical occurrence, and 2) the Brilacidin group still being near the percentage seen in the interim release.
Please cite your evidence that complete B-OM data will show similar drop in results including duration other than market reaction after trash talk and Clay Trader’s group hit, a group that doesn’t give a rat’s ass about data.
What complete fabrication. The data is still compiling and under analysis. None of us know anything and certainly not the market.
What complete bullshit! The B-OM results were better than anything out there including anything currently in trial. It prevented Grade 3 OM in 25% to 35% of patients over the placebo group with no drug related adverse events. What part of that is underperforming?
Agree, except I think we will be at new 52 week highs by then. As for becoming bigkahuna again, that will only happen if I top 100kg again. Has nothing to do with the size of my portfolio. ;-D
And as I’ve often stated, you ignore the full data set and focus only on the top line.
As I said, I’ve been buying. I haven’t been selling. I expect to make a lot of money even on those shares I bought approaching $3. I know what I own. Most people don’t. It’s now just a matter of time. I’ve got time.
I’m still buying, I’ve lost nothing. My purchases have been from under .30 to over $2. Still, I’ve lost nothing and expect to earn a great deal once the IP is fully matured or bought out. That includes share bought over $2. It’s as simple as that. Yet, some make it more complicated for myriad reasons and agendas.
There is nothing wrong with examining possible deals should results turn out to be good. I don’t know why anyone would complain about investigating historical Big Pharma valuations for similar indications.
In spite of all the mythology surrounding free markets, they are not fair, balanced, efficient or reflective of value. Too many participating in the market seem to know the price of everything and the value of nothing. So, yes, the constant misinterpretation of results has lead to a complete under valuation and ineptness. Some of that ineptness is reflected in posts calling a 25% prevention of stage 3 OM a mediocre result.
The OM results were not mediocre. Within moments of the results release many began discussion about disappointment to drive the price down and Clay Trader posted his sell signal with no concern for the PR or data. Some here continue to play the mediocre meme even though top line data showed 25% to 35% prevention over the placebo. In a drug space where there are no effective treatments or preventions, it’s impossible for a 25% result to be mediocre, even though some continue to claim so.
Nonsense. The next phase is 3. That’s already a lock. It’s phase 3 ready. I stand by my statement.
At least 1 Brilacidin is phase 3 ready (UP and OM will depend on FDA guidance). Prurisol will be confirmed Phase 2 finished and Phase 3 ready in a week or two (or 3).
As for Prurisol, jubjective evaluation of Phase 2a included patient comments that it relieved itching and some inflammation so on that basis they wanted to continue treatment. That alone should bolster Phase 3 approval since there were zero reported Prurisol 2b related AEs and thus safe even at 400mg. Though not yet released, P seems a lock for late stage trials.
No one should be in this with money they can’t afford to lose! That said, many here thought the company is derisked through earlier successful trials (note the plural successful trials and still no failures). It is even less risky now than a year ago.
A long time ago, when CTIX was just a startup with 2 preclinical drugs and almost no following, management told me they thought buyout bids would start at around $15 billion if early and mid stage clinical trials proved out. They have. I don’t think that assessment has changed, though as management of a now late stage development biopharma, they are much more careful about what they say and how they say it.
“Gauging from the many negative posts there's a great fear of the price going back to a dollar.“
And then higher. Great fear of that.
I’m buying. Only idiots are holding back. Got my bids filled at open. Bottom is in, Santa Effect coming next week. Amateurs will be selling tomorrow, and pro-hedgers looking to cover, and day traders getting what they can before a long weekend.
There is duration for every patient that endured OM grades 1-3. Brilacidin prevented grades 3-4 in ~25% more patience than the placebo. That means that there is a duration for nearly all patients in the study, except those who dropped out and a few others who did not get OM. The bottom line data will include any differences between in occurrence for all grades from 0 to 4.
It’s not “that simple.” All of the data established up to now will be used to design the next trial. It’s most likely that the oral k trial will start with a bridge study, but will likely focus on absorption and clearance. The PK/PD will simply be confirmed.
He thinks it’s back to the beginning because they are working on an oral formulation. He doesn’t recognize that the oral development can take place while IV proceeds or that the oral formulation only needs a bridge study, not a full-fledged Phase 1 escalation and safety study. There will continue to be a need for IV delivery even after the oral formulation is approved.
You’re right, numbers don’t lie. But, those who post numbers with exclamation points not in the original source and misrepresent the meaning of those numbers do. Without further interpretation and adding context for those transactions—for example how short sales are often nothing more than a transaction temporarily not covered by inventory shares—the daily posting is misleading at best (especially with that added exclamation point).
Here, let me fix that for you:
Nonsense. If you are referring to K-OC, he ran it to better characterize the drug and to aid in determining what drug combos and CAs it might work with and on. The trial has nothing to do with establishing a MTD, or anything beyond more frequent dosing. If that really was a concern, it would be a much larger trial with a new escalation protocol. There are only two dosages and all dosing is well below the MAD.
Nonsense. If you are referring to OM, he ran it to better characterize the drug and to aid in determining what drug combos and CAs it might work with and on. The trial has nothing to do with establishing a MTD, or anything beyond more frequent dosing. If that really was a concern, it would be a much lager trial with a new escalation protocol. There are only two dosages and all dosing is well below the MAD.
Why do you think Frugal Leo scheduled and ran a Phase 2 characterization/MoA study? You don’t think a CDA or two aren’t involved? If there is no BP, then why run the trial at all? If not guided by a BP and what they want to see, there are better ways to advance K or string along K.
Absolutely not true. BP cuts deals for preclinical drugs all the time. They cut cancer deals just for good safety and efficacy in mice. OC is a Phase 2a drug. Yes, it’s a small trial, but the focus is mechanism of action. Greater understanding of its value in combo treatment can come after full analysis.
The CMA usually requires the weight of a BP partner to get past FDA. A BP is best equipped to make a strong safety and efficacy argument. A CMA application for IPIX alone is likely to be rejected not the least of which is due to an unclear manufacturing and distribution infrastructure.
Try cloze?
Looked briefly at a few articles and studies on head and neck radiation therapies. And the >55 Gy seems on the high side of dose ranges from 14-71 Gy. The most common doses appear to be under 50 Gy, and higher doses appear reserved for stage 3/4 tumors among other factors (region, target, etc.). My inexpert opinion concludes that the >55 inclusion criteria was too assure larger probability of severity >= 3.
But what do I know?
It doesn’t matter whether they know or not. Those with severe OM would know there was no improvement and a great deal of discomfort (read pain) trying to swish and then spit. A few placebos would drop out, be unable to continue.
As I said, some are so sick they can’t swish and spit because they have feeding tubes just to take liquids and nourishment. Of course they can’t complete the protocol. In the final report that will no doubt be included, but in top line data it gets discluded and the focus is on PP.
But, I wonder if the exclusion criteria for other trials included the same high radiation exposure? I ask because I don’t know. It seems like all the way around, the design set a pretty high bar, but again I don’t know about other trials. I’ll have to spend a little time researching.
Bullshit! The top line numbers were impressive. There is no scam other than those who keep calling 8 successful trials and 100% success a scam. Where is the scam? Scams in biopharma don’t have successful trials; they don’t even have one trial!
Historical rates would certainly be more accurate. The problem with OM in a placebo trial is that the most severe cases are the most likely to drop out, and in a trial focused on the most severe cases and reducing/preventing severe OM those placebos are the cases most likely to find no benefit or even an inability to complete the protocol.
Could be that, but more likely it was a higher dropout rate for the placebo group. That would easily account for the higher numbers of lower than >3 than previous trials. After all, those in the placebo group would be most likely to drop out if there was no effect. In fact, some of those would not even be able to swish and spit as per protocol.
It’s a breakthrough. There is nothing else out there and it is already far superior to the standard of care, ice cubes.
Bullshit! It means nothing more than they are still compiling data.
It’s still a 40% improvement over the placebo. Also, we don’t yet have the data for duration. This report only covered the one primary outcome for the trial.
Finally, we aren’t looking for breakthrough therapy designation; we are looking for a BP partner who is in a position to more strongly advocate for a BTD. There is nothing out there other than ice cubes.
What’s to ponder? It prevented severe OM in ~20% more patients than occurred in the placebo. What we don’t yet know is reduction in duration, which if I remember was the 80% number in the interim. These are good numbers that should be strengthened with bottom line results including duration as well as can be improved upon in the future.
The Abbvie drug BI 655066 is the most interesting to me. Almost $800 million for a Phase 3 drug but achieved This ASIn90 in 68% of patients. Impressive and sets a high bar for Prurisol. However, some drawbacks to BI 655066, it is injected, treatment lasts 48 weeks, and takes 20-25 weeks to reach PASI 25.
Looking forward to seeing how Prurisol stacks up at 16 weeks by pill.
Why are you still using the f-word for B-OM? Is there some indication for weakness? Do you see something I don’t? If please inform us of the risk using data. I see no f-word risk here. It would require something not yet seen in the interim data. In other words, it’s a lot of crap without something that backs up the discussion. Without the indications you see, it’s just irrational fear mongering.