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Farell, could not agree more. The IBD-UC-Crohn's continuum is huge, but I am still bothered that we have small data, great pictures but no PH 2b. I know BP could purchase early, but that seems just a bit too far out for a good deal. IPIX needs to fund its IBD 2b, then watch it grow. So Leo has to loosen up the Brilacidin for ABSSSI or the Prurisol (if it has good results) to get some funding. We can't just keep our cake and somehow expect it to all come out fine.
KarinCA, thoughts?
Scottsmith you know that BoDs are virtually all creatures of the Executive (See Tesla, etc.). Only advanced economies, for example Germany, require that BoDs to include reps of the share holders, local governments affected, unions, and I think, even the nation, etc. In the US the game is rigged, as we see.
Thanks, Hazelhurst.
I po'd Leo a while back, forget why. And do not get answers, so I stopped emailing or calling. So if you get a return so much to the good.
Hazelhurst, at first I thought you were not kidding.
Dane, I confess, I bought some low. Not a ton, but an itsy bit. I broke my promise to avoid doubling down, a strategy that has not done so well for me these last IPIX years.
I understand the feeling, but talk of law suits is
counter-productive. The company has far too few resources
as it is. We have already had our potentially healthy
dillutions damaged by Rosen/Mako, more legal complexities
and costs are neither healthy nor realistic. We all knew
that little bios are a science risk and a fiscal one. Also,
recall that Leo put lots of his own resources in the company
once up on a time. Just find this talk unrealistic and not
useful.
Rdrunn88, I agree with all you said but would add that it was the courts that messed up Sullivan's (and Leo's)desire to countersue. The Court's allow almost any type of suit that any lawyer will file. Just part of the fraternity in which we small investors in little bios are not members. How many board members have written their Congressmen/women or Senators in protest (none but me, I bet)? Ok, it is futile, but at least you tried.
Good insight, seek the light, imo, the MM's do what they do.
Mack, what good news are you banking on?
A little specificity goes a long way.
MXAMDUD, actually, to a great degree MMs not only know where the stock will be, they direct it there. They can buy, sell, naked short, yes? and even trad out of their own accounts as long as they "trade hats." Though I have not checked this up for years, but still probably so, after all they "Make market." We "hold bags."
Great stuff, seek the light. Many thanks for the dd. Lots to mine.
No problem, seek the light, appreciate your looking. Your posts are extremely veritable so it is fact. Good stuff to know.
Seek the light, where did you find this, I'd love to see the average size, amount of sites, patients, stats, etc.
from Regulatory Focus ( great resource): Phase 3 Trial Costs Estimated at $19M, Study Finds
Posted 24 September 2018 | By Zachary Brennan
Phase 3 Trial Costs Estimated at $19M, Study Finds
The cost of a Phase III clinical trial ranges widely, though a new study pegs the median cost of 138 clinical trials in 2015 and 2016 at $19 million.
“This study identified more than 100-fold differences in the costs of pivotal trials that the FDA required to provide substantial evidence of benefit, with a central cluster of trials with estimated costs of $12.2 million to $33.1 million,” Thomas Moore of the Institute for Safe Medication Practices and others from Johns Hopkins wrote in JAMA Internal Medicine on Monday. “Costs were increased when larger patient enrollments were required to detect a difference from placebo or active drug comparator, and costs were highest when a new drug had to be proved to have clinical benefit that was noninferior to another drug already available.”
In addition, the researchers found that the clinical trials cost a median of $41,117 per patient and $3,562 per patient visit.
But perhaps more important than the median costs, Moore et al said the study provides “a different perspective to the widely held assumption that elaborate and expensive clinical trials are the main reason for the high costs of developing a new drug. These data suggest that high-cost trials occur but usually when drug effects are small or a known drug already provides clinical benefit. On the other hand, pivotal trials for novel drugs with substantial clinical benefits can be conducted at a lower cost.”
In an accompanying editorial, Joseph Ross of Yale University School of Medicine noted the wide range in estimated costs, saying the study “should not be misinterpreted as an estimate of drug development costs and has important limitations because it was focused solely on pharmaceuticals approved in 2015 and 2016 and on individual pivotal trial costs instead of the aggregate evidence used to secure FDA premarket approval or to satisfy postmarketing requirements.”
He also noted that the study suggests that the stronger the evidence that is generated, the more it costs.
“We get what we pay for, and high-quality clinical trial data are well worth the investment to be sure that we prioritize spending our health care resources on therapies that have been shown to benefit patients,” Ross wrote
MXAMDUD, did you really blow your 401 on IPIX? C'mon.
Good theory, hope you are right, fits the evidence well. I remain somewhat bothered by the relative weakness (mainly the small sample sizes) of the 2a data for both OM and IBD. And yes, the pictures are nice, but just seems that for BP to license/throw front money on this scant data seems hard to believe. On the other hand, if a BP wants to get what appears to be good science early and cheaper the time is now. And the potentially huge markets (IBD, Crohn's, UC) can justify a small bet, similar to the one we are all making here now that the pps has reached such a low point.
Govorchin, anything IPIX emails is public. Thought this was discussed here last week.
OMG,I saw your post and sold all. I'd convinced my broker to let me buy on margin so it is really a blood bath. I am calling Rosen (Kidding too).
The problem is that most longs, me included, will not sell on the pumps. If we did, and then re-entered lower, we would have nearly doubled our holding, with the expenditure of no additional coin. Shorts made out, the few big holders did, Aspire probably did, but WE LONGS once again were left holding the bag.
His salary is not outlandish, have you seen what other little bios pay. I can agree if it were me I'd go lower and toss more into research. But it is not me. It takes a certain kind of buccaneer to found/run a little bio. Most of us here are gamblers/investors, and probably would not make good little bio leaders, even if we had the missions raised. I am not trying to make apologies, we are in the penny league and I had bet we would be out of that by now.
Leo is not living the high life on our money, he has invested lots of his own. His salary is modest compared to what, for example, almost killed ADXS, a little bio company of vast potential nearly killed by greedy managers. If Leo succeeds we will too. If he fails we all do.
Lousy engineer, there were some good posts since, saying, "who knows?" A few others seemed to be bullish, though I am not sure why. We have been burned by false bull runs, only to see pps return to a lower rung. Hope this one is real, but as noted "who knows?" We see tomorrow, right? Best.
Recall KarinCA's wise posts about not going nuts (not her words) about evaluations. Trying to evaluate something in the Billions that hasn't even returned a stellar (or any) FDA2b results maybe be a bit over enthusiastic. I see no reason to take a shot a George, I also see no reason to read most of his posts.
JustFacts, nice perspective and true. But would be nice if SEC and DOJ were adequately staffed and funded and did high profile and smaller companies too?
Although I agree with your post for the most part, you may be putting too much emphasis on the SEC enforcement. It is lame, understaffed and has been under the Ds and the Rs. When IPIX faced its unfair, untruthful short attack a few years ago (Mako, Rosen, etc.) it was on its own. Neither the SEC, DOJ nor the courts did anything. Just watched as IPIX fought it itself, and never recovered a dime. Of course there is an SEC, just not for little bios most of the time. This microcap exception is rare, but a big player was involved, which may have triggered their interest.
Unfortunately, scotsmith, you are correct. We don't know. Each runup in the last year or two has been followed by a slow drift down, usually to lower than where we started. We are still a small change act. A 100k purchase (maybe just $50,000)could have come out of some unwise oldie's 401, and bang, here goes the pps. As you say, who knows.
Because, imo Leo wants all the money, honey. Willing to try and struggle it alone, as possible. Either he makes lots for us all or he doesn't. Not much between.
And, if any of this gets done, then the 30 million (or more) needed for the FDA3 for ABSSSI could finally get done.
Going it mostly alone can net the biggest load for IPIX, it is also the most difficult for us "little longs" to watch. Of course this assumes we have some FDA3 potential products. With 5 or 6 or more good shots on goal I am betting/hoping we do.
Your post is interesting, though how are you so sure about K, based on what? Hopefully in the future, but nothing yet to bet on.
It's over, as has been posted many times. Judges do not usually let little bios (or anyone for that matter)countersue other attorneys, despite the facts. Just the way it is. In the US you can get all of the justice you can pay for. But don't upset the system while doing it.
Good stuff, maxinvest, Brilacidin for ABSSSI will be another med in the arsenal for growing MDR strains. One day, when Leo sees a good offer/partnership for an FDA 3 or if IPIX can fund it itself, after other income generating deals, we will see some nice pps boost and the world will have another good anti-biotic in a time of great and growing need. Best
I have been mostly mute these last 18 months or so. The high salaries, the strategic errors and the plunging pps kind of takes your breath (and money) away. Hoping new management can pull some value here before the science grows old. Think/hope it can
Thanks; still think this will do well someday, but the greed and incompetence of management has been hard to take. Gotten so bad I hated to get on this otherwise good board, hard to read about the inevitable. Oh well... just glad I didn't go even harder into the warrants.
Yes, the warrants are and will be below water, and so will I.
I am not sure why careful posters/questioners of IPIX ask if they can share the response. I have always thought nothing can be told or written to any individual stockholder than can not be shared with them all. I hope you get a response, I used to get them all or most of the time, but this last year or so I must have p -- d Leo off, as I get no responses. But I have not raised a question in months.
George, Otezla has passed FDA3, Prurisol has not. We can hope it passes
unfortunately these small numbers don't mean a whole lot. 199 patients in multi sites (from the FDA 2b)is a goodly number and will return statistically significant results, whether we like them or not, and I am betting/hoping we will.