Not at all, I have follow DNDN for ten years and SRPT for 5 years, have seen all
the tricks street and shorts played on them. ARWR may be different because PII
data is 100% repeatable in viral disease and HepB market is huge, with good
PII data, big funds can see the huge potential and tens of billions profits and they
want big part of it. ARWR is perfect fit for GILD, first generation HepB cure:
ARC-520+Viead+INF, second generation cure: subQ ARC-520+combo
of Viread+GS-9620, IMO.
ARWR may break $6 by next Friday, and $8 to $9 by Sept 23, IMO.
What ever the data is on Sept 24, Hedge funds and MM have a very
good idea what they are, and plans to make hundreds of million profits, IMO.
Thanks for telling us the information you got from ARWR. I listened to the 6/3 presentation again
and I do not get the sense CEO backed off the answer he gave on the Q2 CC. I think we are going
to have some very surprising good data from the three new cohorts on Sept 24th.
Sorry, My mistake, the Q&A was on ARWR Q2 earnings CC on May 11th.
I am long, and if there is one multiple dose cohort, it is a big surprise and
huge good news, IMO.
The question is clear and direct to PIIa' three cohorts, and so is the answer that ARWR is not
telling single or multiple doses. I just think it is strange answer.
what do you see here during Q1 CC:
Alethia Young - Deutsche Bank
So have you guys said if it is single or multiple doses that you're going to be studying in the next cohorts?
Christopher Anzalone - CEO
We haven't said that.
Michael Yee - RBC Capital Markets
Okay. Last question, sorry to come back to it, but coming back full circle. In the additional cohorts, this has to all do with the Phase2A, correct? This is all single dose stuff, correct?
Bruce Given - COO
Yes. This is the Hong-Kong study, this is the 2001 study we are talking about we have added three cohorts to that study.
Christopher Anzalone - CEO
We haven't said if it's one or multiple doses, however.
Is it possible the three new cohorts have at least one cohorts is multiple doses which I guess
may be the double blinded one?
FC for HepB: first to market ARC-520 + PEG-Interferon(Roche)+ NUC(?) OR
ARC-520+GS-9620(GILD)+NUC(?), it is just a matter of when the deal can
be done, IMO.
GS-9620 is being considered as well as a component of a cure strategy for hepatitis B, a virus that also has evasive tactics that allow it to hide from the immune system. In a study of woodchucks -- animals commonly used for hepatitis B studies - - viral loads were undetectable after four weeks of treatment, giving them a “functional cure” that remained even when treatment was stopped.
In a chimpanzee study, a short course of therapy provided long-term viral suppression, encouraging Gilead to move into human trials.
Gilead’s work on GS-9620 also may open the door to more acquisitions like the one that made the company the leader in hepatitis C, Roden said. Harvoni combines Gilead’s drug ledipasvir with Sovaldi, which was acquired in the 2012 purchase of Pharmasset Inc.
“The blueprint for Gilead’s M&A in the past has been to integrate assets in an area where they have expertise,” said Roden. “It’s the combination of assets that has the most value.”
Ex CEO fought FDA hard to open the door to AA.
The short case is remarkably similar both of SRPT
and ARWR, it seems a group hedge funds get a order
to kill SPRT and ARWR's drug platform by denying their
ability of going to market for funding and shorting the
stocks as low as they can get away at all cost. In the
end, the best drugs may win.
SRPT was and is in the exact same positions with ARWR, first class
drug for DMD, but shorts say toxic drug from BMRN may win,
huge short position. Now the tie is turning positive on SPRT, the best
drug is winning now. We will see the same after ARWR' s AD, IMO.
Well, JPM owns 3.2M, 5.5%. It means something JPM is a largest share holder
of small cap biotech, we do not see that often.
Can GILD cure HepB without ARC-520 for its $15 billion potential? JNJ, MRK and BMY may also
compete for ARWR, GILD is in the lead position again.
On its own, it also has GS-9620, an interferon alpha ligand and Toll-like receptor 7 agonist, in phase II testing against HBV. Data are expected later this year. In that trial, Deutsche Bank's Karnauskas noted, Gilead believes that it does "not need to see a complete S antigen conversion, but would like to see a signal that clearly indicates a reduction of S antigen to move into [phase III]," though she acknowledged that the "key unknown is how much of a reduction in S antigen is required to drive a functional cure." Overall, Karnauskas
predicted that HBV could be a $15 billion opportunity for Gilead.
Be cautious about NLNK hot talk about blinded MOS 30 month, only
thing for sure is the initial assumptions for statistical plan in SPA is
wrong, IMPRESS may still be success at final, but needs a huge
steep separations at 18 to 20 month time mark to make up loss
in P value in the first 18 month of no separation, the way P value
is calculated, no easy task, IMO.
in Sept which I believe is going to validate the IDO platform,
street is going to trust Roche's data. For all those years, NLNK
is wasting money and time on those open single arm trials,
and control-placebo trial results are delayed for years, if you
look at NLNK's presentation last Jan on JPM conference,
NLNK said PILLAR and NSCLC PIIb initial results in Q4
2014 or Q1 2015, here we are, both trials are still enrolling
patients, I wonder if NLNK management know what they are
I am not giving up yet, I am surprise to see RCPT estimate peak sales of
MS only $1.4B, but UC $2.5B and Crohn's $1.3B. In this case, I see RCPT
is a right target for GILD to diversify because GILD has a news drug GS-5745
(MMP9 mAb inhibitor, different MOA) in PII trials for UC and Crohn's , and RCPT
is a a good fit for SHPG too.
Sorry about the deleting my posts, just want to say forget about IMPRSS
until the final results next year, If my DD is correct about PIIb NSCLC data,
we may see very strong efficacy, do not know when NLNK is going to PR the long
over due data release, I bought in yesterday again, and intend to hold this
time, I do not see down side under 50, IMO.
Now I see RCPT is perfect fit for GILD, SHPG and AGN for them to
expand into new therapy areas, I still do not understand how RCPT
sold it self for $232.
If AGN wants to expand into Inflammation and autoimmune diseases,
RCPT is the perfect target for AGN, and they are aggressive to buy
what they want, we will see in next two to three weeks, IMO.
TEVA is not out, but AGN may be in:
Teva sees capacity to continue executing deals in 2015 and 2016
Allergan to use Teva deal proceeds to pursue other deals, Reuters says
Allergan (AGN) CEO Brent Saunders said it will use the $36B it receives from the sale of its generics business to Teva (TEVA) to pursue further acquisitions, Reuters reports, citing a company conference call. Saunders told investors that proceeds from the Teva deal will be used to increase the size of its existing drug businesses, expand into new therapy areas, and seek out larger deals, the report says.