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Dew,
I have not been following Ihub boards enough to know where you stand with MNTA---are you still holding?
It is interesting to think back to what a different company with different investment thesis this was a decade ago. With the evolution, a lot of colorful investors and pot shots have come and gone on this and the BTV board. Thanks again for your diligence and intelligence.
Flo, you deserve major commendation for your steadfas, due diligence in following of MNTA going back at least since 2007, when I first started buying shares. The road has been tumultuous, so please savor your rewards now.
By the way for those who bought with an average price back then in the $5-10 range, the buyout price is 5-10X. Even spreading that out over 13 years, not a shabby return and I learned a lot on the journey.
With thanks to you, DEW and the other stalwart crew on this journey, thank you.
Urche/jerry
Re: Sensitivity/specificity of COVID-19 -antibody tests
My own attempts at research over past few days and that Biocentury A\article makes it clear to me that the rush to create antibody tests is a wild, crowded field with info that is challenging to process in real time.
Indeed, the article published on April 10 may already be outdated. It states that Cellex is the only company to receive EUA for Covid-19 antibody test. But, it seems that Hardy is distributing a test produced by AutoBio. The AutiBio test seems to have better sensitivity (95.7-99% for IgG and IgM, respectively). I think specificity is likely to be the more important criteria to focus on, because a test that cross reacts with coronaviruses other than COVID-19 would give dangerous results, suggesting false immunity. The reported specificity for the Autobio test is 99%.
By they way, the Cellex test is already in use at a tiny hospital in VT: https://tinyurl.com/re43gq4
Reviewing the company specs on the test, the reported sensitivity and specificity are somewhat lower than the source cited by DEW (95% sensitive and 91% specific). That seems not good enough to me for widespread utility.
In summary, for me it is very reassuring to find so much happening to develop antibody tests, but I am not yet finding any investable prospects. Becton Dickinson looks worth watching.
Antibody testing
Anyone here have a handle on what companies or institutions are most likely to lead the way toward development of commercially available Covid IgG and IgM antibody tests? It seems to me a product that will be in huge demand and hugely valuable as nations decide how to ease restrictions on school, work, and social interaction. Even if it is not a profitable product, who is going to do it? Abbott? Amgen?
I read a news story about some private companies and institutions working on it---not investable options.
I am new to this board, even though I have followed the company even when it was Tekmira.
Glad to see Dew hanging out here!
I am curious what theories we have about why the sudden spike in volume, seemingly on no news since the disappointing trial results about a month ago. My own theory is that the activity starting at the open yesterday is related to sales data released by Alnyam. As I recall, ABUS gets royalties from Onpattro and maybe another Alnyam drug.
Here is snip from the Alnyam PR this week:
For the rest of the year and beyond, we expect steady and continued growth in patients on ONPATTRO therapy through improved disease awareness, new patient finding, expansion in global markets – such as our recent launch in Japan and NDA filing in Brazil – and the potential for future label expansion in hereditary and wild-type ATTR cardiomyopathy through our recently initiated APOLLO-B Phase 3 study. We’re also pleased to have received a Priority Review and Accelerated Assessment for givosiran from the FDA and EMA, respectively, and we are preparing for the potential launch of our second RNAi therapeutic in the coming months, assuming positive regulatory reviews,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam.
Other theories?
Curious about HOW Express Scripts would incentivize the 20 mg daily dose. Does the pressure get applied to the providers writing the prescriptions or patients paying their portion of the cost? And would it be thru education or economic pressure to switch?
Having held shares since 2007 (and gone silent years ago when I got disenchanted with all the legal wranglings) it is time to reevaluate holding MNTA. I had always assumed that after copaxone approval there would be a nice pop and a good time to sell some or all of my position.
But, once again, the case for holding seems, if anything even more compelling. I agree with Tony, Flo,and others that MNTA still is a good value. Even more attractive to me is that, after years of tenuously clinging to a high risk hope, this stock is a lot less risky now.
Urche
PS: Great to see Old Berk still lurking
That article about cabo in combination with erlotinib is the only piece of news I have found. Could that be the reason for the 7% jump today? Seems far fetched to me.
Urche
New on this board, but long term holder with renewed interest after big drop on Fri.
This drop appears to me to be due to Alnylam's implied claim that it owns patents needed by ARWR to commercialize its Hep B vaccine.
Suspect that options and stops played a role in the drop, but not primary reason.
I need to review recent news and will be following more closely.
Urche
Everolimus as a gold standard?
I admit to not being up to date on treatment for Renal cell carcinoma. But is everolimus really a reasonable standard worth comparing in a head to head trial? I hope this will be a study worth running.
Urche
Huh? What's the chart telling you?
Urche
As in the past, there appears no reason to sell this stock, nor any reason to be excited about near term catalysts. Management seems to execute so quietly that there is no reason not to go back to sleep for another year, I think.
Urche
Nothing happening as far as I know. I did call the number given a few months ago and sent email with my holding info. But, no response. I have since tendered my shares thru Vanguard for the tax loss. Game over for me.
Urche
EXAS
From the link you posted regarding the colon cancer screening test being developed by EXAS:
generic bioequivalence
I suggest that this conclusion is irrelevant at best and more likely devious.
These findings suggest that simple analytical characterization can establish good quality control in manufacturing but may not assure similarity in biological performance between branded and generic enoxaparin. Thus beside the routinely required characterization, inclusion of additional tests for biologic activities and pharmacodynamic profiling of generic products in animal models may provide useful information on the bioequivalence of the generic versions of enoxaparin.
It shouldn't be surprising at all that differences in characterization of the product manufactured by different methods from different substrates could be found if one looks hard enough. Indeed, I suspect the same could be said about the product produced by a single manufacturer (Sanofi vs. Sandoz) from year to year. That level of difference is probably going to be clinically irrelevant, in my opinion. But, we'll never know without a head-to-head trial.
The real, important question is not likely to be addressed by either company, nor by any regulatory agency: Do the documented variations in batches result in any meaningful differences in patient oriented outcomes. Therein lies the expensive question that no one wants to address, because of the expense and risk.
Just MHO,
Urche
Ebola.
Sarepta---bingo!
Actually, that program is now defunct. So, as far as I know the only therapeutic/preventive program against Ebola virus is Tekmira's.
As this snip states, Sarepta's related Marburg therapeutic program is extant.
Oct 03, 2012 (Marketwire via COMTEX) --Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-based therapeutics, received notice from the U.S. Department of Defense (DoD) that the Ebola portion of the Company's contract for the advanced development of hemorrhagic fever virus therapeutics was terminated for the convenience of the government due to funding constraints. The DoD's Joint Project Manager Transformational Medical Technologies (JPM-TMT) awarded this contract in July 2010 to advance a platform capability for treating both Marburg virus and Ebola virus. The Marburg portion of the contract remains in effect.
Ebola vaccine
Interesting article on Ebola. By the way, the temporary stop work order on Ebola vaccine research was lifted recently for Tekmira, so that company is back at work on Ebola under contract with the US Gov't.
What eludes me is the name of another company that was working on a therapeutic for Ebola. I think that company's stop work order was not lifted. Anyone recall that company or know if any other companies are working on treatment for Ebola?
Urche
Interesting trading pattern
Regarding Tekmira and Alnylam, it is interesting and baffling to me how they are trading today.
I would have predicted ALNY to drop about 5% today reflecting its loss of IP and cash settlement. But, after initial drop of that ilk, it is actually up 5% today. Loss of overhang from getting the legal quagmire settled is all I can figure for an explanation.
Tekmira is up about 15% for the day, but I expected much more than that considering that the enterprise value of the company approximately doubled overnight! It had EV about 58M at yest close. Now it is due $65M, plus another $10M expected in near term milestones, minus about $16-18M legal fees). So that is, in effect, a double in EV at the same time that its legal overhang has been resolved.
This seems like a compelling small cap value---- unless I am missing something.
Urche
TKMR, ALNY
This is a momentous settlement that will remove a huge overhang on both companies.
After reading the separately slanted, but largely congruous PRs from the two companies, it seems a victory for Tekmira, which gets to keep most of the IP it should consider core to its pipeline, and will get $65M in addition to other future royalty payments. Conversely, ALNY will be eating a $65 M restructuring charge and the nefarious Alcana company is barred from work with RNAi for 5 years.
I have no idea how the market will perceive this, but as a holder of TKMR who also sold my hedge in ALNY, it feels like a favorable outcome. However, I still think ALNY would have had a better outcome in the long term if they had just bought TKMR. Pride and spite ruled, I think.
Urche
INITIAL PRETRIAL CONFERENCE
Thanks for this confirmation of INITIAL PRETRIAL CONFERENCE, presumably prelude to class action suit against YA.
FWIW, I did send email to the address given a month or so ago with my share info---no reply.
Any advice on whether there is anything to lose by taking the shares as a tax loss this year? Vanguard has a procedure to buy my shares for $1 to get them off their books and do the documentation needed for claiming a loss. Is there any reason I would be sorry to do that this year?
Urche
RNAi
I am into RNAi the way you, Dew, once said you were into cancer companies---no more than one high risk bet at at time. So, my money is still on Tekmira, although I admit to being somewhat disillusioned by its legal quagmire of suits, a countersuit, and patent controversy. In that regard, it rivals MNTA----it takes a lot of the interest out of following them for me.
The other company that I nibbled on but got indigestion was Arrowhead.
OB, did you ever buy into TKMR?
Urche
Regulus
AC,
Your guesstimate that AlNY's share of Regulus may be down to 12-15% would be consistent with the figures reported for other ownership shares.
To summarize ownership of Regulus , we have record of the following:
ISIS 18%
GSK and SNY about 10% each
AZN 18%
ALNY (estimate) 12-15%
Given that the IPO was for 11.25 M (33%) of the total 34M shares, it follows that ALNY's ownership is closer to 12%.
It has been a dull stock in terms of trading pattern. Since the IPO, it has only swung 10%, from $4.02 to $4.44 on low volume. So, there seems to be little interest, little hype, and, so far not a target for speculators---all of which suits me fine since I am thinking of accumulating a small holding.
Urche
Regulus
Ever since selling the only "star" in my portfolio, Alnylam, another star has been born, Regulus.
It looks interesting to me for its IP niche and early pipeline.
But, I would appreciate any help and opinions trying to understand its current ownership and financial situation.
Since it was a private joint venture (originally 50/50 ISIS and ALNY, but I believe SNY and GSK ended up being owners also), the IPO has obviously changed the ownership picture a lot.
This is what I have pieced together:
ISIS must have freed up shares to allow the 34 million share IPO, and then, in a bullish seeming move, bought 750K more shares on Oct 10, and reportedly still owns 20%.
AZN bought 6.2M shares to bring its ownership up to about the same---18-20%.
SNY and GSK also bought shares after the IPO and reportedly own about 10% each.
ALNY I have not seen any filing on its current ownership, but certainly now less than 50%, and probably under 20%.
It follows that about 60% of shares are in hands of ISIS, SNY, GSK, and AZN; and 40% of ownership is presumably in the hands of ALNY and the public float now.
Does anyone have other relevant info on the RGLS financial situation? I would hope that they have minimal debt, and at least a years worth of cash, but also a lot of projects in the pipeline to eat up whatever cash they got from the IPO.
I got no response from IR, who undoubtedly has more important folks to talk to than me.
Pondering this one,
Urche
Is this statement taken out of context or am I missing something?
TKM/SRPT
Interesting timing and interesting story with these two companies.
Obviously, this news was favorable to Tekmira, which jumped almost 10% today.
At the same time, Sarepta received news that its Ebola program remains defunded by the Dept of Defense. This ordinarily would have been a big negative for a small company like SRPT. But,of course , all this was massively overshadowed by the results from its muscular dystrophy drug--- the 200% rise of SRPT today gives it a market cap just over $1B. Is anyone besides me feeling this is out of line for a drug that is probably years from approval in a population that is small and will presumably require life-long weekly IV infusions?
Even though I am heartened to see validation for a drug based on antisense technology, I can't help but sense that Sarepta is going to be the victim of short selling pressure and dilution for further studies from here.
Urche
That Seeking Alpha article seems to have another agenda, IMO.
I can't argue that NVS has threats looming to its pipeline. But, it seems preposterous to me to posit that an OTC drug from a tiny company poses a serious threat to NVS in general and Diovan in particular. This article seems more a way to promote "Chromadex Corporation's (CDXC.OB) patented pTeroPure® (pterostilbene)" than downplay the NVS pipeline with any credibility.
I would want to know why I am calling. Is John's interest in amassing shareholders to participate in a class action lawsuit? If so, is it against Cobalis or the allegedly unscrupulous debtholder(s)?
Urche
I sent an inquiry to this address this am:
John@driversalert.com
No response so far. Has anyone else talked by phone or heard by email from these guys?
Urche
Thanks for the response about what excites you about Response.
I will be watching to see if a plan emerges that has hope of growth in their main product sales. Approx $3M in sales per quarter is not chicken feed, but I want to see a plan forward.
Urche
I have stopped following this company after years of thinking it was promising.
What holds your interest in Response for the future?
Urche
Dew,
Thanks for your candid response to Biopearl's pointed questions. My sense is similar to yours, that no matter what happens to the share price tomorrow, the effect is likely to be short-lived and the patent trial loss does little to affect long term (2-3 yr) value. So, I think the answer to Biopearl's question about whether to sell MNTA at this point depends entirely on one's time horizon as an investor. Short term traders will sell because of the perception that this stock will flounder for many months, and long term traders are likely to see a buying opportunity if they think the market overreacts. I say this adverse legal outcome was priced in.
Urche
Did Shea really pay $.61 per share?
If so, he could sell those same shares tomorrow for >$700,000 profit on his $28K investment. Doesn't that seem like an unusually cheap option price, even if it was acquired 5+ yrs ago?
Urche
I'd be interested in your DD results.
This company is hard for me to come up with a valuation a whole lot higher than it is now because they seem to be opting for a model of being gov't funded which makes it unlikely to fly in either direction. But, it also seems to be building up a solid foundation, and getting the gov't, rather than stockholders, to finance the development. I like not being diluted repeatedly.
But, I am mainly here because it is in my SEP IRA where the loss won't do me any good to realize and I have a lot of faith in the CEO from prior experience with another company. So, this is one to just read the annual report and let it ride, IMO.
Seems like you could get .32 within a few days just on usual spreads in this thinly traded stock. I like to think there is a longer term rationale for holding this company.
Urche (long for >3 yrs.)
HDL-if the brakes of your car are damaged....
Your analogy is weak. But, to go with it, when my brakes are not working, I want to figure out which one (i.e. HDL subtype) is the problem.
Your point is well taken that there is no proven causal relationship between HDl and cardiovascular risk. Yet, for some reason people with lower HDL or higher Total Cholesterol/HDL ratios tend to have higher risk. The question is: why? A plausible hypothesis is that HDL is simply a marker, perhaps analagous to the C Reactive Protein or homocysteine stories. But, the hypothesis I think is well worth researching is whether genetically determined subtypes of HDL are behind the confounding data. If some types are cardioprotective and others are harmful, then we could certainly design therapies accordingly.
I think it is time to let this thread rest.
Urche
HDL genetics
This academic discussion of polymorphism, mutations, and semantics infused with dignified suggestions of insults has been very informative. I am in awe of the knowledge on this board.
But, I am not sure I understand the distinction Genisi suggests:
HDL genetics
Thanks, Genisi. Please help me understand our understanding of the genetics of HDL.
I am wondering if HDL subtypes are well enough understood to show the relative cardioprotective or risk profile of each type of particle. If so, do you think we are at a point where a study of the genetics of HDL subtypes, one's personal HDL fingerprint, so to speak, could be traced to one's genes?
If so, then it seems plausible to start designing treatment more specific than just trying to raise HDL, which may be a target too blunt and complicated to be clinically useful.
That's a lot of ifs.
Urche
Those folks with the Apo A1 milano variation seem ripe for further study of the beneficial HDL hypothesis---assuming their cardiovascular risk is really lower, which seems simple to verify.
If I recall correctly, the IP associated with therapeutic use of Apo A1 Milano still resides in the sub-basement of Pfizer as a result of the Esperion purchase?
Urche
HDL may not be so Good afterall
This news has been getting a lot of press this week. In addition to the Globe article referenced, the NYTimes ran a prominent article yesterday.
The news is actually based on an article published so far in online issue of Lancet. The summary is pasted below for reference. But, the article is quite technical and hard to understand for someone not versed in modern genetic terminology. My own take is that the correlation between HDL and cardiovascular risk is more complicated than we thought and HDL could even be a marker for something else that is more directly causative.
However, I find it odd that the study apparently did not study the famous group of people with the Apo A-1 Milano variant who I thought clearly had a demonstrated profile with higher than normal HDL and lower than normal cardiovascular risk.
I suspect the next step will be to tease out effects of the various subtypes of HDL, some of which I predict will be shown to be cardioprotective and some may even be associated with increased risk.
This news upsets long held belief of mine that raising HDL, at least natural HDL (as opposed to the abnormal HDL particles associated with CETP inhibitors), is beneficial and a promising investment thesis. My long floundering investment in Resverlogix warrants further scrutiny.
Urche
The Lancet, Early Online Publication, 17 May 2012
Plasma HDL cholesterol and risk of myocardial infarction: a mendelian randomisation study
Summary
Background
High plasma HDL cholesterol is associated with reduced risk of myocardial infarction, but whether this association is causal is unclear. Exploiting the fact that genotypes are randomly assigned at meiosis, are independent of non-genetic confounding, and are unmodified by disease processes, mendelian randomisation can be used to test the hypothesis that the association of a plasma biomarker with disease is causal.
Methods
We performed two mendelian randomisation analyses. First, we used as an instrument a single nucleotide polymorphism (SNP) in the endothelial lipase gene (LIPG Asn396Ser) and tested this SNP in 20 studies (20 913 myocardial infarction cases, 95 407 controls). Second, we used as an instrument a genetic score consisting of 14 common SNPs that exclusively associate with HDL cholesterol and tested this score in up to 12 482 cases of myocardial infarction and 41 331 controls. As a positive control, we also tested a genetic score of 13 common SNPs exclusively associated with LDL cholesterol.
Findings
Carriers of the LIPG 396Ser allele (2·6% frequency) had higher HDL cholesterol (0·14 mmol/L higher, p=8×10-13) but similar levels of other lipid and non-lipid risk factors for myocardial infarction compared with non-carriers. This difference in HDL cholesterol is expected to decrease risk of myocardial infarction by 13% (odds ratio [OR] 0·87, 95% CI 0·84—0·91). However, we noted that the 396Ser allele was not associated with risk of myocardial infarction (OR 0·99, 95% CI 0·88—1·11, p=0·85). From observational epidemiology, an increase of 1 SD in HDL cholesterol was associated with reduced risk of myocardial infarction (OR 0·62, 95% CI 0·58—0·66). However, a 1 SD increase in HDL cholesterol due to genetic score was not associated with risk of myocardial infarction (OR 0·93, 95% CI 0·68—1·26, p=0·63). For LDL cholesterol, the estimate from observational epidemiology (a 1 SD increase in LDL cholesterol associated with OR 1·54, 95% CI 1·45—1·63) was concordant with that from genetic score (OR 2·13, 95% CI 1·69—2·69, p=2×10-10).
Interpretation
Some genetic mechanisms that raise plasma HDL cholesterol do not seem to lower risk of myocardial infarction. These data challenge the concept that raising of plasma HDL cholesterol will uniformly translate into reductions in risk of myocardial infarction.