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.
Sounds a bit like you are surprised that for once da hick got something right.
Ain't no stupid people living in the woods here abouts, big feller. In the grave, several. Lotsa rodents thou. Though big ones, scare bears silly jumpy. Try to shoot a jumpy bear. No fun, git many dead squirrels that way. And darn rodential critters eat mine molasses, bstrds! :)
No clue how they stopped mice from swallowing or biting. Furthermore, I really, really don't want to know.
rodential = rodent like, or mouse like
typical usage: "Mr. X looked rodential"
As I said, speculation. But based on some noteworthy observations.
Polymedix recorded astonishing > 90% reduction of SOM in mice. Granted, it is mice we are talking. Still, the reduction was achieved with brilacidin pouch stuffed in rodential cheeks. That provides longer contact time with mucosa than any reasonable oral rinse. How are we going to do that with humans? Ask them keep big pouches in their cheeks day after day?
Hehheh... might make them look adorably cheeky... but NO.
Sticky slowly dissolving tablet a la Validive is possibility. I happen to think the best solution is to inhibit proinflammatory interleukins as early as possible via IV. Especially if it can be shown that IV once a week is sufficient.
My main point: BP has several very talented scientists at its disposal. I would be really surprised if those scientists think that the level of efficacy achieved by IPIX is the end of development process.
BLATANT UNINFORMED SPECULATION:
How about this:
Low concentration brilacidin IV once or twice a week combined with Brilacidin oral rinse to combat SOM. Currently, due to negligible absorption thru intact epithelium Brilacidin is active mostly in late stages of SOM development - preventing the spread of infection and reducing inflammation after ulcers have formed. Superoxides generated by radiation do cause cells to release proinflammatory agents well before that, but behind the wall formed by epithelium. Combination of oral rinse and IV might be able to reduce SOM incidences even further than rinse alone. And because Brilacidin has plasma half file about 20 to 24 hours it might be possible to administer IV only once or twice a week.
If I were BP I would be looking into possibility, if only because it could be the fix for weekly cisplatin problem. I have a reputation of being slightly off kilter... so, who knows, maybe I am grossly mistaken.
Yeah. For permit to spend freely one needs the magic words 'strategic investment' preferably at hefty (> 500 % in IPIX case [which won't happen, but hey ...]) premium over going SP.
What? Are you saying mice don't care about their offspring? How do you dare!!! You can be a hero and a caring parent the same time.
My advice for your mouse: Take first a hefty life insurance and then head for Celgene pre-clinical research labs at Summit, NJ.
Yup, my guess is that BTD verdict will probably affect how much BP is willing to pay upfront.
Now, let me muse about something a bit unusual (besides the common deep dive to IP rights and protection) what BB might be doing as a part of its DD, because I certainly would if I were in their shoes.
I would dig into IPIX's data from all Brilacidin IV tests and trials and see if there is any indication of at what concentration B becomes effective anti inflammatory. And if I could not get satisfactory answer that way I even might tell IPIX that I need to do some quicky mice tests before committing.
Why? Well, let the audience (if I have any) figure that one out as a weekend assignment.
Ah, that's the mystery. IPIX is not divulging. And no company seems to be willing to admit publicly of being this particular CRO. Go figure. I gave up some time ago.
Drug discovery usually means preclinical research. See page 5 in your link:
"In a crowded space, why should you consider Charles River for preclinical drug discovery?"
Underline mine.
Dead end. Charles River Labs specializes in pre-clinical research and would have nothing to do with prurisol phase 2b clinical trial. They did, probably, provide BALB/C mice for pre-clinical Imiquimod induced psoriasis studies. SCID mice for xenograft studies was likely from Jackson Laboratories.
Possible Discussion Topics for the Initial Comprehensive Multidisciplinary Breakthrough Therapy Type B Meeting.
Lilkahuna, doesn't the initial Type B meeting happen after BTD application has been approved. I don't see any meeting with applicants in BTD approval process. Be kind and advice.
Thanks. Clarified some things I have been wondering about.
Things seem to be getting a bit loony. I though we have no way of knowing the amount owed, barring distant viewing and other esoteric skills.
But... I truly hope that this is not tactless: If we have above sort talent here I like to inquire about the cost of services. I.. er... have few documents I would love to have a peek at.
Does your answer mean
You think we would know if we were in arbitration over prurisol clinical trial payments.
OR
You ask if I meant to ask: Would we know if we were in arbitration with CRO over prurisol clinical trial payments?
Being an immigrant some finer aspect of English language escape me. I meant the latter.
LilKahuna, I agree that a drug with BTD is more likely than the one without to manage with one phase 2 trial and even be approved based on single phase 3 trial. But I don't see these advantages being provided by BTD per se. They are more like consequences of proven benefits that were anticipated but not promised by BTD designation. FDA is very careful in its wording about BTD benefits concerning clinical trials:
These trial designs may result in smaller trials or more efficient trials that require less time to complete and may help minimize the number of patients exposed to a potentially less efficacious treatment
Doesn't mean that a company can't use assigned BTD as a 'proof' of FDA's belief on potential efficacy of their drug (FDA does think so) and even as evidence for potentially rapid commercialization (if all pans out as anticipated, FDA will oblige).
ffrol, would we know about arbitration?
Uh? I thought that's what I said. OR at least intended: BTD was designed to help applicant to accelerate process thru late phase 1 and phase 2 with no meaningful benefits after phase 2. But I did not know that getting BTD after phase 3 has started would force a trial design resubmission. Interesting.
No you did not miss anything. FDA prefers to have BTD application before successful (important distinction) end of phase 2 meeting, otherwise most of the benefits of BTD are lost for applicant. And because FDA does not see BTD providing much, if any, benefits to company past phase 2 it might even decline to issue it after successful end of phase 2 meeting.
So logically, if applying for BTD, even only for marketing reasons (ala Galera:phase 2 trial --> BTD --> end of phase 2 meeting --> phase 3; nil intended benefits from BTD to Galera) gets delayed what does company do with application for end of phase 2 meeting? Goes ahead and squanders bragging rights for BTD. I don't think so.
"I get the impression that there may be some principle at issue"
I would not disagree. Size does matter. If this CRO had been working for big pharma one can bet it would have been made to eat the cost overruns (been there, done that... actually, I was there when my boss did that). Micro biotech don't carry same kind of future work muscle.
"It took 10 months to ask for a meeting?"
Dear TIAB. If you had read FDA guidelines you might have been able to hazard a guess by yourself.
A test of advanced reading comprehension and logic:
https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm
Hint: the last paragraph sort of gives FDA's preferences away.
Pete, that kind of arrangement would results in cult like behavior on both boards making them Devil's version of AA: place for people to meet and support their addiction not fight it: Self appointed and crowd anointed enforcers of the 'righteousness' would banish people for expressing their mildest disagreement not to mention trying to correct misinformation. If you take an objective look at 'the other IPIX board' you see what I mean. A word from history comes to mind: Sturmabteilung.
We need a board where civil discourse provides checks and balances for bullish and bearish hotheads. So far, this board is the closest I have found (granted, minuscule universe to search). Not perfect, prone to storms in both directions and some juveniles can be more than aggravating but at least one is not unquestionably and immediately stoned because of his/hers opinions.
The fact that 'Alabama Shakes' is on his jogging playlist impressed me.
That would have impressed me, too. Thanks for the story, Detonate. Maybe this old yarn by a fella to whom I might have given an advice that he is bound to do better if the stays in the art school can serve as a comment on your decision to curtail your time.
Groton, just one possible scenario that Leo needs to consider. I assume that negotiations with suitor number 1 are still ongoing.
1. Current term sheet is exclusive and it falls thru.
2. Second suitor signs a term sheet, also exclusive. Science DD may be done already but time is needed for legal/financial DD.
3. Repeat until a deal is done or all suitors are gone.
We can only guess what are the time estimates on this. And nobody is paying Leo for lost time.
Indications PDE4 inhibitors approved by FDA
1.Otezla/apremilast - plague psoriasis, psoriatic arthritis (big bucks)
2.Eucrisa/crisaborole - atopic dermatitis a.k.a eczema (bigger bucks?)
3.Daliresp/roflumilast - chronic obstructive pulmonary disease (COPD) or smokers disease.
and, of course,
4. Diazepam/Valium - various indication
Add to that Brilacidin's promise in ABSSSI, SOM and IBD and one must wonder when and from where the big bang is coming...
Okay, number 4 is a joke, sort of. Valium IS PDE4 inhibitor among other things it does, soo...
Dud, you must be using jewish or islamic calendar.
What!!! No torpedos. Thanks, Loanranger. Somehow I DO trust your honesty. I know, a fault in my personality.
That's my reading, also. But I am like you... no idea how common the clause is.
Agreed, Karin. I think that the clause is there for a reason and, this time, not because the buyer insisted on it! ... Waiting a torpedo from Loanranger to hit :)
I would call it optionally reversible stock sale.
I edited.
Who has read a lot of share purchase agreements? Would those persons tell me how often they have seen this:
"Following 30 days after the initial closing, the Company may elect to redeem the preferred stock for 120% of the aggregate stated value then outstanding, plus all accrued but unpaid dividends and all liquidated damages and other amounts due in respect of the preferred stock"
And with examples please. There are too many 'opinion artists' here for me to trust plain opinions on this one.
Not that much different from Bertolino's short term priorities from september 20th press release:
“Near-term strategic clinical priorities remain: to work closely with the FDA and other regulatory authorities to align on the remaining development plan necessary for Brilacidin in Oral Mucositis; to analyze the Prurisol Phase 2b data in Psoriasis; and, as additional funding becomes available, to commence work on new product formulations—1) an oral pill for Kevetrin in Ovarian Cancer; 2) an oral pill for Brilacidin in IBD; and a topical application for Brilacidin in Atopic Dermatitis and Acne.”
You know, the press release where we found also this "...partnering discussions ongoing, as well as active efforts underway to secure additional sources of capital ...".
Is it possible that you are reading too much into current wording, or were they already in Sept. 20th hinting that the term sheet fell thru?
"One doesn't have to be a nuclear scientist to agree with this simple logic." you are right. Simpleton will do.
How true. Oh, how true. I cannot fault Loanranger, thou. I have a habit of tripping over my words and convoluting the intent. Must be due to my bloodlines. No good comes when slavic tendencies to pathetically romantic melancholy gets mixed with nordic tendencies to stoically pathetic melancholy.
Again:
We know that in August 2018 one non-binding term sheet was signed by IPIX and unspecified BP. That's the limit of current facts. Adding anything to that is an assumption probably beneficial to assumer's cause.
Let me end with this:
Last night while attending to my anti-rabbit urine duty I spotted a coyote lolling by. A thin, forlorn prince of the night. Today we have gray melancholy skies. My mind is revisited by the bitter romance of childhood's cold, stoic winters. I feel my blood wants to follow that pathetic prince down to drown in big rivers.
How pathetically romantic convolution is that.
Sigh, Loanranger, I have failed miserably. I started this in order to point out how futile any statement about
1. How many CDA may have resulted in negotiations for term sheet.
2. Why there is only one signed term sheet we know about.
then it evolved discussion about
3. If IPIX did dictate the term sheet to hapless BP
4. If BP did dictate the term sheet to clueless IPIX
I am expecting further development along the lines
5. Which party in IPIX vs BP is slapping the table with bigger <reader's choice>
....
and so on
....
and so on
Interesting question. All I know is what is in the document I linked earlier:
"Some owners add variety to the restrictions on exclusivity. If a prospect
receives a purchase inquiry, the owner may prohibit the prospect from
responding and may require the prospect to pass the information along to
the owner so as to prevent a "flip" of the transaction."
Not the same as preventing the prospect from pursuing other buying opportunities, but might do.
"If true, this obviously advantages the prospective buyer:"
Well, who has the money? Also, do we know that the agreement over a term sheet was reached with the first prospective partner? Maybe IPIX dropped some suitors for being too stingy, maybe some suitors dropped IPIX for being too greedy and so on. It is silly (but sort of predictable) to make a case either pro or against IPIX based on what little we know. And that is the case I considered closed, which obviously was bad choice of words. Is case(s) dismissed better?
Yup! So many possible timelines... I have given up trying to guess what and when. Still, I have eerie feeling that next 2 weeks will be interesting.
Thanks. I think the case is settled with this post.