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SS, all we DO know is that there is one signed non-binding term sheet. We DON'T know the rules of negotiation specified in it. For instance, if a term sheet has an exclusivity clause then there can't be other term sheets or negotiations over same drug in parallel. Some pharmas do insist on exclusivity clause, others don't. That's all.
Below link is quite good in explaining:
https://www.americanbar.org/content/dam/aba/publications/blt/2004/07/question-of-whats-binding-200407.authcheckdam.pdf
Yup, you are my kind of people, DaubersUP.
"Second——BTD was initially denied and resubmitted - this could be what deal is waiting on"
Other explanations do assume excessive stupidity well outside mean pharma level +- 2 standard deviations.
Loanranger, I agree totally. However, what you are saying was not in the original statement I protested. Different animals.
I found some
Polymedix from MidCap
BioHeart from Bank Of America
Aveo from Hercules
CytRx from Hercules
...
Plus number of companies on this page from Hercules Capital website:
https://www.htgc.com/portfolio/
It's strange how little effort it took.
Have you checked, say, Paratek Pharmaceuticals? Can't guarantee what you find, but judging from SP history I would say it is a good guess that some stellar promises must have been made in the past.
https://www.nasdaq.com/symbol/prtk/stock-chart?intraday=off&timeframe=10y&splits=off&earnings=off&movingaverage=None&lowerstudy=volume&comparison=off&index=&drilldown=off
For those not inclined to stare stock charts: Accoridng to Fidelity during year 2007 Paratek had split adjusted share price around $ 400 to 500. Now it is about 10 bucks or equivalent to about 98 % loss for the investors since. They might soon, depending on FDA, have only 95 % loss.
ABSSSI trial was done using eStudySite, a clinical research site organisation. eStudySite provides clinical sites and site management services but NOT data analysis services --> blinded data was sent to IPIX for in-house analysis. Hence IPIX was able to comment about blinded data. Not the case with prurisol trial using full service CRO.
Thanks farrell90. Comprehensive summary about what and where IPIX's science is.
I get you now and agree with your assessment on our situation.
I sometimes wish that our anti-Leo posters would have graduated from Kriegsman (CytRx eternal Chairman and CEO) School of Investor Manipulations. They would probably be still critical (and with reasons) but the language and perspective might be different after dealing few years with the Zombie.
[ending tangect starts]
I still wonder how a drug with aldoxorubicin's pedigree and history of being unbeaten in one-on-one comparative trials against most of the current treatments for STS plus potential to do impressive feats in combination with olaratumab has not yet had NDA filing. Takes certain type of talent to mess that one up, but the Zombie seems to have it in abundance.
I may have confused you. I was speaking about small upfront payment in case of BP taking over drug manufacturing, development and commercialization. Upfront can be cash payment or 'strategic investment' at good premium over going share price. Maybe enough for the licensor to survive solvent until first milestone payment, but only if the licensor limits activities to sittin on their asses.
A recent example: CytRx got upfront $13M 'strategic investment' at 92 % premium from NantCell in licensing deal for aldoxorubicin. Cytrx was on private placement market about 9 months later. As a personal comment about the 'greatness' of CytRx deal, I think that it may take 2 more years before CytRx sees the first milestone payment, if ever.
I suspect that Leo is trying to negotiate something better.
Possibilities for a prospective partner:
Number 1: Partner can reserve the right to approve how the upfront payment is used plus include a clawback clause in the agreement to make certain that it's wishes will be followed.
Number 2: Partner will take over any further production, development and commercialization of Brilacidin for SOM and IBD. Upfront payment would in this case be non-assigned and non-applicable towards future payables (milestones, royalties) to IPIX AND significantly smaller than in case no 1.
You are right, it does not involve IPIX, yet. Still, I would love to see data from all those failed trials become available. Might make 'prediction business' a tad less unpredictable.
About time, say I!
Because BTD does not chance FDA's requirements for approval, mid stage plus BTD is still mid stage. But BTD does provide FDA's support for development plus some priority response times... maybe "accelerated mid stage drug" would be a good match.
No quarrel with that.
A Tangent: A presumably educational story not requested and offered as demonstration that IPIX is not my first cow in a ditch, as some say in my neck of the woods.
Late 2016 I watched Olaratumab jump from phase 2 to $20k per month treatment for STS via AA. Nice memory: I did my DD, concluded that this time Lilly's science was not just valid, but exceptional and thought that AA had a very good change to happen. So-called PRO:s laughed and countered that Olaratumab's approval will be long ways off. That prediction did not make me rich, BTW. AA did not even change SP's downward direction.
But they still call phase 2 mid-stage and phase 3 late stage.
Maybe it was a 'forward looking' statement. I would call B a mid-stage drug candidate, when (not if, but when) it enters into p3, then ... Seems to be FDA's take, also:
"Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies."
Quote is from here:
https://www.fda.gov/forpatients/approvals/drugs/ucm405622.htm
Thanks, LR. Looks like this time I didn't mess up too badly.
"It'll be hard to avoid some serious dilution in a private placement (or a convertible preferred deal)"
Yup. The reason why you did not see me applauding the possibility. There in those quotes above stands the reason (well, one of them) why some people say V in VC stand for VULTURE.
Thanks for helping in diagnosis of the state of my sanity. Not in-, yet. I have been thinking along the same lines as you, and looks like for the same reasons.
You could be correct with your sense. As I said: I have no firm evidence.
Sometimes people have been ousted because they ended up opposing a deal favored by CEO. Sometimes investors demand that their person will replace a person in management. IPIX has avoided venture capital like plague up to this point (or vice versa). Maybe IPIX can't anymore and because of that we have management shuffle followed by private placement. Of course I don't have any firm evidence to support any of this.
That's it. Now I wait schooling from LR. We have this lovely tradition: I ignore or misunderstand something (or several things) and get terse educational note from LR.
May be just the opposite.
Galera specifies 60 minutes IV ending an hour before radiation treatment.
Galera's presentation data at Vienna was somewhat confusing. For example: their swimlanes do show 35 SOM incidences for 76 subjects (ITT) in 90 mg group, but they report percentage of ITT (43%) that gives 33 incidences, while swimlanes for placebo show 45 SOM incidences for 74 subjects (ITT) while they report percentage of ITT that gives 48 incidences.
Both deviations from swimlanes make GC4419 (lower SOM rate for GC4419, higher for placebo) look better and the opposite directions of 'deviations' make reasonable explanations hard to come by. BUT, probably just coincidences, or something like that, because, as SS says, Galera is a real company. Real companies do not fudge their data.
If you use swimlane data then GC4419's SOM incidence rate would be 61 % - compare that to 60 % reported by IPIX. SOM incidence rate for 90 mg GC4419 would be 46 %. IPIX reported SOM incidence rate for brilacidin to be 43 % in 21 subjects.
If you use swimlane data to construct Kaplan-Meier estimates for GC4419 90 mg and placebo you get this:
A. curves for placebo arm in Galera and IPIX trials are virtually identical with Log-Rank hazard ratio 1.01 (calculated IPIX trial over Galera).
B. Curves for Brilacidin and GC4419 90 mg are near identical and Log-Rank hazard ratio favors Brilacidin just so slightly, HR ~ 0.95.
Conclusion: So far no evidence for superiority of either drug.
Please do. That would be appreciated.
Sir, sometimes you make my brain hurt. I guess it is a good, educational thing. Hurt. I see you point. I, for my part, do favor possibility 2 with no facts to support it. Call it optimistic delusion.
Aawgghh, KarinCA. You had to tell me this! I was not, quite typically, at all aware of compassionate use. I had this nice little scenario already fixed in my mind.
1. IPIX files BTD application well in time. It contains roughly the same information as in their Jan and Aug 2018 corporate updates.
2. FDA rejects the application, but with guidance saying if IPIX will include certain information FDA might consider granting BTD.
3. IPIX looks around and, look, they do have it, but were just too ashamed to show it to FDA in the first try.
4. Modified BTD application gets filed sometime in August 2018.
Getting really speculative. I mean, the following is laying it really thick, but there are worse liars here around - so why not.
Term sheet was signed in August 2018. Potential suitor must have been aware of FDA's rejection and about requested additional information, took a look at IPIX additional data and concluded that IPIX probably has BTD at hand and decided to sign non-binding term sheet with IPIX.
What would the info that FDA was after be? How about this: Include patient level data for weekly cisplatin Per Protocol group. Kaplan Meier curve for it looks like the stuff below. Anybody can create it by deducting August Kaplan curves from January curves.
The really weird thing is the fact that the above Brilacidin curve still has hazard ratio edge, by Log-Rank, over Galera's GC4419, HR = 0.87 favoring Brilacidin. I guess you can now guess why I like this little scenario.
Have great weekend and do some biking :)
I am with you on this. I can't come up with even half bad reason why the application for BTD would have been filed no later than first week of July. It's not that complicated document to compose.
Sorry to say but I lost contact with them when I moved out of the city and they left for west coast. But what I learned in NY is this: Philippine people are some of nicest and most generous people around. I still have a silk shirt she brought me from a vacation trip home. I won't fit in it anymore, not for years, but I keep it around as a memento of great times with lovely people :)
I don't think so. My understanding of this sachet business is that the change boils down to putting the same powder used in P2 trial to mix the rinse into pre-measured sachets. That eliminates one step from the process - measuring the correct amount of powder for mixing. But I may be wrong - I never bothered to look closely how B was administered in P2.
If you are looking for reasons why FDA might have rejected the initial BTD application and we are now in refiled stage: maybe FDA wanted to have more info about systemic exposure to Brilacidin in P2 SOM trial. Just a badly educated guess, based on Brilacidin history in ABSSSI.
No issue with sample size, FDA has approved BTD:s based on very small p1 trials. As to alternate doses, I think IPIX probably included mouse data from Polymedix to show that 3 mg dose should be near optimal. Anyway, approval of BTD application does not mean that FDA will go with initiation of phase 3. Maybe FDA asks to see first a dose ranging trial or a trial with different delivery method altogether. They can be ornery, sometimes. Although, the latter is more likely what the potential BP could be thinking.
From BP:s point of view the value and structure of deal depends significantly on what happens with BTD and end of phase 2 meeting.
Otezla's sales growth is badly yo-yoing, plus it did not do that convincingly in ulcerative colitis trial. So I say, maybe ...
No. For BTD FDA does not require the same level clinical proof of efficacy than for marketing approval - I would say 'reasonable' expectation for improvement is enough, especially when there is no approved therapy for the indication. Brilacidin P2 trial does meet that 'standard'. In my opinion even fuzzy results with weekly cisplatin do not warrant rejection of BTD application.
But, FDA is free to disagree. They are also free to ask clarification for any part of application they please. And sometimes they really do please a lot - well beyond being an impartial gatekeeper.
A question with a gentlemanly tip of imaginary hat:" Madam, is your nom de plume after certain fabulous French-Armenian singer?"
Care to speculate, ffrol? (others welcome, also)
What does it mean that BTD for B-OM is still in play?
1. That we have management willing to announced milestone loan agreement based on getting BTD for B-OM by the end of September and then proceeds to sat on application until it was possible that FDA's response would not come in time?
Or
2. That the management filed for BTD well in time and got FDA's no cigar response with FDA's advice how to get the said cigar. Then went to work and refiled, presumably being sane enough to follow FDA's instructions?
Or
3. For some flabbergasting reason the potential BP stalled IPIX filing for BTD until FDA response was likely to be late for milestones?
If you think, as I do, that we have the case number 2, then there are some further speculative statements possible, including this:
Whatever was the FDA's reason for the original rejection it must have been something that the IPIX management thought fixable without additional clinical work.
Highly speculative, of course, but if correct, encouraging.
Little clarification, FDA has made it pretty clear that it prefers to get BTD request in before end of phase 2 meeting for the same drug. And, FDA can reject or grant a request for end of phase 2 meeting regardless what happened to BTD request - they are substantially different requests.
How do you interpret word tentative? Of course there will be PR silence if the end of phase meeting is not granted.
Doing the show, even with negotiations ongoing, makes sense. That trip is about making relevant people aware of Brilacidin. Even from potential partner's point of view this is a good thing - makes recruiting sites for clinical trials a bit easier if you show up with a drug the good doctors have heard about.
It is a two stage process. FDA will respond to a request for end of phase meeting within 14 days. If the request is granted the response will provide the date for the meeting to be held within 70 days (end phase meeting). All times are counted from the date FDA received the request.
FDA draft guidance to formal meetings can be found here:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf
The above makes me think the next (tentative) PR will be about scheduled end of phase 2 meeting.
No there was nothing in the link about 'upfront royalty percentage", I agree. But there was about upfront payment with portion earmarked for debt payments. I don't know if those were related to the drug being licensed.
You don't think it possible that BP might make an investment in IPIX? A private placement deal for 10M or 20M shares at price well above current SP to goose it up also.
LR, I did little research. Found a range:
1. Tightly controlled - Upfront payment with designated uses listed. May even include specified debt payments.
2. BP says so long for a chunk of money - Non-refundable, non-designated and non-attributable payment.
3. And anything in between.
ffrol seems to assume that IPI does not have leverage to avoid the first possibility. I dunno...
Unless, of course, if IPIX somehow manages to trade future royalty percentage to unrestricted upfront money or even designated to be used to payoff IPIX debt.
See Salix- Napo agreement here:
https://www.lawinsider.com/clause/up-front-payment?cursor=ClMSTWoVc35sYXdpbnNpZGVyY29udHJhY3RzcjQLEhVDbGF1c2VTbmlwcGV0R3JvdXBfdjYiGXVwLWZyb250LXBheW1lbnQjMDAwMDAwMWUMGAAgAA%3D%3D
Anyway, I doubt that will happen and it would eventually be very costly to IPIX. But desperate times ... maybe Leo will sell his wife's furniture and extend IPIX an additional loan.
Okay, it might be time for LR to spank me over this.
Yeah, I did. Getting close with IPIX. Maybe the potential BP prefers to deal with UPenn. And what's with me and links ;)