(Cont.) - Here is what I want to see/hear on AD:
1. Clear & compelling evidence (CCE) showing a clear path to FC. The evidence needs to be data driven based on high quality science. If ARWR claims that chimp data is predictive of results in man (as they must believe), they need to show high quality data supporting this claim. If ARWR claims their chimp study resulted in FCs, they need to show that this is both reproducible in chimps & that the chimp data show with a high degree of certainty that this chimp data is predictive in man, even if only for a segment of the HBV population.
2. CCE showing RNAi knockdown is the missing piece that has prevented FC in all (or a definable but significant segment of the HBV population) but a few pts until now. IOW, but for effective RNAi knockdown, FC has eluded the field. With effective RNAi knockdown, there is now a recipe to FC in hand. The level of specificity of that FC recipe is important; it relates to the level of predictiveness between chimp FC and human FC.
3. CCE comparing & contrasting ARC-520 to the competition. Just how far ahead of the competition is ARWR? In terms of timelines? % knockdown? Duration? & most importantly, safety? What exactly is known about the safety profile of ARC-520 vs. TKMR's vs. ALNY's.
The above needs to be explained in clear/simple terms that would convince a jury of lay people (and a jury of HBV clinicians as well as a jury of Wall Street analysts) that ARWR has a clear & achievable "recipe" to FC. A recipe is not simply here we are today (no FC) and this is where we want to be (FC). A recipe is a list of ingredients & instructions that if followed will reach the desired result. It has to be clear that by following the recipe (maybe tweaking it here or there), FC is assured. Or if not assured, highly likely. The recipe must be supported by clear & convincing scientific evidence to support the view that FC w/in ARWR's reach & that ARWR will get there before the compet.
Ram, you just shifted from "recipe" to "roadmap."
CA's statement about recipe to FC needs to be heard in the context of the question asked by the analyst and Bruce Givens' very measured somewhat evasive (or perhaps just noncommittal) reply. CA then interjected that recipe to functional cure language. I initially felt he was laying down the gauntlet about what Wall Street should expect at the AD. So firm was my impression that I thought he had used the phrase "roadmap." When I went back and listened again, I realized he used "recipe" instead. (Post to be continued.)
Ram, please recall CA's near final words during ARWR's last earning call:
"Keep in mind that the goal of Monarch is to find the recipe that gets us to functional cures. Once we find that recipe, we will then blow that out with larger studies, of course. And we are taking an open architecture approach to finding that recipe. We are, been, agnostic about what combinations we'll do as long as they are safe and they make sense theoretically we'll try those combinations."
I suppose CA's use of the word "recipe" will suggest different things to different people. I read that to mean ARWR has more than a mere hope of achieving FC at some perhaps future point. AT AD, they need to put on the table at least "a recipe" (or even better, "a road map with turn by turn directions") to FC. JMO
"Lets get some things straight and manage some misinformation.... Roche has a ROFR [Right of First Refusal] on any commercialization program with the first five indications ARWR decides to develop using the DPC platform."
Lol. Holden manages to create misinformation as he purports to dispell it.
Here is what CEO C. Anzalone says:
"[Roche "received limited rights of first negotiation, uncertain future product candidates, late-stage milestone payments that are not triggered until after drug approval, and low single digit royalties." (Source, excerpt from introductory remarks of C. Anzalone, 10-24-2011 Transcript of cc re ARWR Acquisition of Roche RNAi Assets, page 6.)
"The way that’s structured is that for a limited number of certain product candidates they will have the right to negotiate, to partner or to acquire those. They’re structured in such a way that it will not materially impede our ability to partner those, but it will give them a chance to negotiate for them." Id. at page 28 (Q&A).
IOW, MrsBodacious is buying here. When she posts "Strong Buy" she will be selling. She is pathetically transparent.
Read ARWR's November 14, 2011 press release. It states that Leonardo Bio is "a portfolio company" of Arrowhead Research Corporation.
Hparch, a few questions:
1. What is the level of your confidence that BIND's Accurins are "precisely like" ARWR's DPC?
2. Does this change your "$200-300 mil market cap" statement about ARWR?
3. What is the level of your confidence that BIND's Accurins infringe on ARWR's DPC patents? Can you point me to web pages that relate to these issues from both ARWR and BIND's perspective?
4. ARWR acquired DPC from Roche. Subsequently, Roche entered into some sort of collaboration with BIND. How do you think about such a collaboration? Does this suggest that DPC's are somehow functionally different from DPC's? Why would Roche sell off DPC's only to collab with BIND regarding identical Accurins? Was Roche just kicking BIND's tires to fully confirm for themselves the identical nature of Accurins? Any light on this will be appreciated.
Earlier today you said, "DPC appears to be so incredibly special, one has to ask why, and why there aren't other systems like it?"
In response to another poster you said, "BIND is interesting - their delivery product, Accurins, is precisely like ARWR's DPC (polymer encapsulation, targeting ligands, etc..), and their web site indicates that they can deliver all sorts of payloads as a drug delivery platform, including RNAi, as well."
1. Were you previously unaware of BIND?
2. When did you first learn of BIND?
3. Does the existence of BIND temper or lessen your incredibly bullish statement made earlier today that "an eventual $200b - $300b market cap for this type of capability [meaning for ARWR].... [T]his is serious stuff, everyone. It could have ramifications well beyond anything that we have been seriously contemplating at the moment..."?
You said, "DPC appears to be so incredibly special, one has to ask why, and why there aren't other systems like it?"
Have you looked at BIND Therapeutics? I would very much like to hear your thoughts comparing/contrasting ARWR's DPC to BIND's Accurin.
"Sanofi announced today that the LixiLan-O Phase III clinical trial met its primary objective in patients with type 2 diabetes...."
UNIS' "Imperium is a prefilled, disposable, multi-day wearable insulin pump that does not require filling or assembly by the patient. Because it is prefilled and pre-assembled like an insulin pen...."
"LixiLan is the Fixed-Ratio combination of Sanofi’s Lantus® (insulin glargine), the world-wide most prescribed basal insulin, and Lyxumia® (lixisenatide), administered as single daily injection via a disposable pen." - See more at: http://globenewswire.com/news-release/2014/02/06/607924/0/en/Zealand-informs-that-Sanofi-has-announced-initiation-of-the-LixiLan-Phase-III-clinical-program-for-the-Fixed-Ratio-combination-of-Lantus-and-Lyxumia.html#sthash.pXuPpGVU.dpuf
We all know your m.o. When you say "Strong Buy," you are a seller simply looking to goose the sp. You are fooling no one and your effort to deceive is pathetic.
AS stated he had several deals done in everything but execution sometime around May/June of 2013 (if my memory serves). No names of companies were mentioned. The actual Sanofi deal wasn't officially announced until about the following September and then the Hikma deal soon followed.
Not sure if the above answers your question.
Just yesterday Investron asked essentially the same question of Wyattkap so there can be no legitimate reason for him to avoid answering your question.
Nevertheless, I suspect he will ignore your question because of extreme embarrassment.
Good luck to you.
Holdencf said, "I don't see how they dose humans by YE?"
ALNY's roundtable HBV presentation did not assert they are going to dose humans by year end. They said they are going to file the Clinical Trial Application by year end and that those [early stage] trials will be concluded by year end 2016.
That said, I was not impressed with ALNY's HBV roundtable presentation.
Questions that Should be Asked during the next UNIS Conference Call
1. Pursuant to the terms of the global strategic agreement with AbbVie entered into on January 15, 2015:
a. Has UNIS received the $5 million payment from ABBV for the exclusive right to form and enter into a mutually-agreeable development and supply agreement with Unilife?
b. Is there a time frame or date by which the development and supply agreement must be finalized and executed? If so, what is that date?
c. Can you provide any additional color regarding the timing and status of those negotiations with ABBV?
(Anyone else have any suggested questions?)
"If ARWR Were $70 Today We'd Be Complaining"
---Investron, you have long been the biggest complainer on this board.
"There is nothing to say."
---Investron, you are the king of saying a whole lot of nothing.
"All these stupid posts trying to justify the price play into the shorts' hands."
---Investron, Exhibit A of stupid posts are your relentlessly stupid posts.
"ARWR can be cranking out better and deeper pipeline than ALNY such that it will make the superiority of DPC very clear."
---Maybe that will be the case in the future but that is clearly not the case now and wasn't the case when you stupidly and arrogantly recommended shorting ALNY $50+ points ago.
ALNY has at least 5 subcutaneously administered compounds in the clinic (i.e., in man) right now.
Despite the fact that you claim "ALNY's website still has the product pipeline bar chart in the 'development category,'" other sections of their website as well as press releases clearly show/state that the following compounds are administered subcutaneously:
1. Phase 3 clinical trial of revusiran in transthyretin (TTR)-mediated familial amyloidotic cardiomyopathy (FAC);
2. Phase 1/2 trial of ALN-CC5;
3. Phase 1 clinical trial with ALN-AS1;
4. Phase 1 clinical trial with ALN-PCSsc; and
5. Phase 1 study for ALN-AT3.