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Zipjet,
I'll take a listen when I get the chance as well (also want to listen to MAKO's presentation).
Did you pick up anything of interest from the call?
I do have to agree though with Jq (not having listened to the call myself yet). EXEL, to my understanding, is planning a 2H 2011 start. I doubt if recruitment can be completed in 2011, so that moves into 1H 2011. If survival is an end point, no way the trial finishes prior to 2H2012, more likely 1H2013. Prostate cancer survival, late case, from my experience with DNDN, you are talking 12-18 month survival expectation under the SoC, and that is just the median. If the drug is really making an impact, the beneficiaries will live longer than this, and we can hope much longer (although with provenge it was a 4 month advantage).
If the end point is pain, or some other shorter end point, then it could end quicker.
The trial should enroll quickly however, given the current results. Assuming the February data comes out and does not tarnish the present stunning results, there will be no problem enrolling in the trial, and it may be one of the faster enrolling trials we will see for cancer.
I'll let you know if after listening to the call I have a change of opinion, but I to have heard many an aggressive timeline in clincal trials, and I've never seen one pulled off (at least one that succeeded in the end).
But, then again, if this drug's results maintain their dramatic efficacy, as the early 19/20 results, yeah, I guess it may be able to move through quickly.
Company, that could have sat on its cash printing laurels, is betting the company on it. Either they have some real confidence (as they could have continued to print stock options), or they are just crazy!
I'm sure we've both seen both mental states turn out to be true in the end.
I do own some EXEL shares, so I'd love to see a rapid fire boom-boom to market, but things are as they are, and usually they are as Jq is indicating, no matter what management says.
Thanks Zip.
No fret however, if further data comes out (like with VRTX) that shows incredible and undeniable efficacy, the share price will continue to rise until there is little upside to waiting for the NDA (picture AMLN, probably left 20-30% upside in the end for the NDA, which is why I sold out prior to the NDA in AMLN. I'd wager the same will happen in EXEL as the data, if it remains consistent, will be that transparent for the market to see and project forward).
Tinker
Bioisimilar phase IIs continue:
http://www.reuters.com/article/idUSLDE7090BP20110110?feedType=RSS&feedName=rbssHealthcareNews&rpc=43
It will be interesting to find out what biosimilars (bioidenticals), MNTA is pursuing. I found it interesting that Novartis is going it without MNTA technology, which you would think would practically insure the identity of the drug and thus the result of the clinical trials (even if one were going the similar route vs. the identical route, with clinical trials).
Tinker
Which may allow Teva to convince the Judge that NVS/MNTA’s patent-infringement lawsuit should be dismissed as moot, averting legal discovery that might be highly embarrassing to Teva.
Does anyone have a link directly to this Goldman Sachs presenation by Marth?
Tinker
What will remove the fetter off of MNTA? The most likely thing will be copaxone approval. Until Teva's credibility on the Street is dissolved, it is mCopaxone that will be the next major catalyst for the stock. Said decision should come before the tLovenox issue wears down as a fetter.
In that regard, it is up to the FDA how they want to handle it, but I am confident that MNTA has characterized and reversed engineered mCopaxone just as they did mLovenox. mLovenox may be screwed up stock wise because of the contract, but mCopaxone has the appropriate contract in place.
This will give MNTA even more credibility on the Street once the FOB candidates start rolling out. The Street will have to give credit for mCopaxone earnings, and give real credibility to the fact that MNTA may very well bring FOBs to market. Therefore, mLovenox, in the long run, will fall back as a cash cow but not the driver of the stock that it initially was.
Then again, if 2011 passes and no tLovenox and no aLovenox, some eyes may open up as well.
Tinker
Triple damages if you launch at risk and lose at court.
So it is a real risk, and given NVS's size, not one worth taking unless it is pretty clear cut they are going to win at trial.
Tinker
According to Teva, the FDA said it is not completely clear how Copaxone works, so the agency cannot be certain the new version would be as effective.
I have to strongly agree with Dew on this one. The FDA was quite clear that even small differences in lovenox would alter the drug. That is no different with Copaxone. MNTA has stated that they have fully characterized copaxone. They have proven the analytical skills to be able to do so, and to do so with methodology acceptable to the FDA to prove that they have done so.
That is a far cry from Teva with an attempt to reformulate copaxone as a life cycle product management tool.
This is actually quite bullish for MNTA. It shows that an Indian knock-off is not gonna cut it. You need true sameness, as was required for lovenox. It is doubtful that anyone else will be able to meet this standard but MNTA.
Tinker
It looks like the pessimistic player initiated a debit put spread, buying 2,000 lots at the January 2011 $12.5 strike for a premium of $0.45 each,
Aren't you forgetting to subtract Momenta's $60 million dollars/yr expenses from the Lovenox cash flow?
How to value mLovenox if tLovenox somehow gets approved?
How about this, in a multiple generic scenario with Teva and an authorized generic, $40 million to MNTA seems to be the most probable result. How much is that income stream worth? Would seem to have a low risk of being maintained, and would grow with the lovenox market, tha lower priced generics would encourage.
An acquirer would need to pay a 35% or so in taxes. Tha would leave an annual cash flow of $26 million per year. How much do you pay for that? 5x, 10x, 15x? $250-$400 million at 10-15x. That is about the worse case scenario that I can envision for lovenox, and even at this MNTA will have a patent suit to defend its turf.
Current marketcap of $694 million - cash of, well a lot of cash. $170 million, $220 million. Worse case mLovenox seems to equal almost the entire value of the current enterprise value of MNTA, at least at 15x.
You can also do a DCF with this number instead of applying an arbitrary multiple. Using a DCF, with a 10% discount rate, and a 10 year growth rate for lovenox generic market of 4% and a 1% terminal growth rate, I get $417 million for the value of the after tax profit stream. Putting it into perspective of what an acquirer might pay for it to give us an idea as to how to value this worse case scenario.
Tinker
to a $15 12-month price target.
I was looking at the increase in insider sales at MNTA:
Yes, one director just sold $1.9 million worth of stock in the $14s. Maybe that director needed a few mil for a new house, or is moving off the board, or some such reason. But that does not garner a heck of a lot of confidence.
In regard to the other selling, automatic sales yes. However, I'd have to think by now that all the tax selling is over, and insiders are selling with the automatic program about as quickly as they can get around to it. That is a subjective response as I have not calculated it, but that is what it looks like at a glance.
There is potential for immediate upside if mCopaxone gets approval by the FDA. This will create an immediate share price rise, but then will be tempered by the lawsuit on Copaxone. A positive Markman ruling will also be positive for the shares. It should be tried in 2011, but appeals could last into 2012. A loss puts any mCopxone on the market in 2014/2015 and we don't know how big the Copaxone market will be at that time with the new orals coming on board (or at least oral). Still should be worth a few hundred million per year to MNTA even if Copaxone takes a dramatic hit by 2015.
It presently looks like M118 is not going to garner a partner, at least not with the type of terms MNTA was looking for. FoB program is probably the strongest in the industry, but that is still some time off, absent a very lucrative partnership arrangement that could be announced at any time.
All in all, insiders don't seem to swayed by this potential upside news. But it does exist.
Of course tLovenox, even if it is just be cheating and stealing MNTA IP is an immediate material detriment and clearly is what the market seems as the most likely near term catalyst.
Tinker
I doubt very much if clinical trials will be required for generic copaxone. Think about it, either it is the "same" or it is not. How are you going to test if it is the same, run a clinical trial and see if the results replicate copaxone? That won't work.
As for safety, sure they can run clinical trials for safety, but sugar water is safe. A copaxone that is not the "same" can also be safe. It it is the same, then it is equally as safe and equally as effective (calling copaxone "effective" is somewhat of a stretch as sometimes I think a placebo would be more cost-effective, but give it its due, it sells $2 billion per year).
As MNTA identified with lovenox, multiple criteria that demonstrably showed "sameness" and in fact identicalness. MNTA will most likely be doing the same for copaxone. The factors may not be identical to that by lovenox, but I believe the protocols will be similar, with each specific element tailored towards copaxone.
Given the way that Teva is behaving (and we had this discussion on MNTA and Teva lovenox earlier today) Teva is panicked that the FDA is going to approve MNTA's copaxone application. They have good reason to be.
No, clinical trials do not seem likely, or in fact anything helpful at all given the legal process involved. Past complex generics that no one gained approval on have not required clinical trials either. It is what Teva is demanding however, which is the only reason I brought it up.
My concern is primarily with the on-going litigation. A loss there would be devastating. There is also the FDA risk, but I think that less than the litigation risk. Having to wait until 2014/2015 to launch mCopaxone would be devastating. Who the heck knows what the MS market will be in 2015. The value of a sole generic may be much less by then, and I don't like to wait 3-4 years for a fruition point.
But that is more the focus of my concern, and perhaps it is overblown. We will find a lot out when the Markman ruling is made that defines the patents at issue in regard to what the jury is to consider.
Tinker
Fear? MNTA management obviously has been and always will respect its competitors abilities
I don't think there is much doubt that this raise was done for fear of Teva. It may be true that TEVA cannot possibly meet the FDA standard unless they cheat and steal MNTA's IP.
If MNTA is more worried now than before, I think, as evidenced by the lawsuit, is because they think that Teva may very well be closer to approval due to theft of IP.
A patent suit is not a perfect remedy, and in fact is often a benefit to the infringing party who makes more money from stealing the IP than from paying the legal fees and eventual penalty years down the road.
I think there is a legitimate risk of TEVA gaining approval through stolen IP. Which is perfectly consistent with Dew's opinion of the issue as Teva could only get approval through stealing the IP, and not on their own accord.
With the remedy of a patent suit, if Teva launches at risk, money in hand now will be very valuable. It would have been nice if they had raised while in the $20s, but how quickly the share price fell surpised us all, and I doubt the underwriters could have pushed the shares at the high price so quickly when buyers were noticing how rapidly the share price was falling.
The Bernstein note, coincidentally timed, sealed the fate.
All in all, if copaxone gets approved and the lawsuit on copaxone ends positively this 9% or so dilution will be long forgotten and nobody will care. But for MNTA management, if the worse case happens, they still want to make sure that MNTA continues as a viable entity, without having to scratch and scrape and layoff, and reduce their aspirations. So from their perspective, it is something they needed to do.
To me the raise felt like a slap in the face, but we have to face it, the primary party of interest in public companies is management. They are 100% invested in the company, whereas shareholders can get out in 2 seconds. From management's perspective it was a very prudent thing. I am really surprised they limited the raise to $56 million or so with that perspective.
Tinker
<<<and having $220-230 million in the bank (and A/R) at year end>>>
Is this the counting that people get that MNTA will have $220-@30 million in the bank by the end of the year, including A/R + add in $56 million or thereabouts?
Tinker
My impression was the same as yours 10, they don't know. They don't think it is necessarily impossible. The lawsuit indicates that they think, if it is possible, it is because they utilized MNTA IP to do so. Which leaves the lawsuit shield.
Which is a good reason to raise money because just because someone is violating your IP it does not matter until the court says they are and makes them pay damages. As an example, the DRAM industry stole RMBS's IP for nearly a decade and then only paid a relative pittance to what was actually taken. Cost RMBS $10s of millions to fight.
This IP case will be more limited and simpler, but litigation remains endlessly uncertain until it is finalized. Which could keep the lovenox issue up in the air for years. Meaning MNTA may be denied these revenues for years, until they prevail in court, including appeals (assuming Teva posts what would probably be an enormous bond to secure the award first as would be required).
Now if MNTA can get the FDA to approve copaxone without clinical trials, then that issue may become irrelevant. At least for awhile, pending the current copaxone litigation, if they can ever get their Markman ruling and get the case going.
Tinker
P.S. if they had to conduct clinical trials, that would be something like 2 years or so I would estimate. I doubt very much the FDA is going to make MNTA conduct clinical trials, but that would largely make moot the on-going litigation.
In any event, I am looking for copaxone approval out of the blue, like lovenox approval was, as the next big catalyst here. Perhaps a partnership, perhaps a favorable Markman ruling as well.
Okay, most of that was not covered in the presentation, but you have to look at it holistically.
Looks like TEVA is trying to replace copaxone. Another safe but only modestly effective drug. And given that Teva released none of the top line results, that is probably what it is as well. Still a few years away from approval. But with this profile it would cannabilize the copaxone market, as that is what the copaxone market is. I think Teva would only do this if MNTA was successful in its copaxone program. TEVA is always thinking ahead however. I am sure they will find a way to try to make it accretive, but this would appear to be another way for TEVA to recover from a generic copaxone. Which will get to market first, generic copaxone or laquinimod? I'd wager generic copaxone by a few years, but it is still up in the air.
"The safety profile of the product is good and there were no alarming signals that worry us," Ben-Zion Weiner, Teva's chief research and development officer, told Reuters.
Deutsche Bank analysts said in a client note: "Given its putative profile as a potentially very safe but modestly effective drug, we see it as fitting a niche in patients with early-stage or less aggressive disease."
Zipjet,
I don't think it is much of a mystery anymore that tysabri is nearly a miracle drug for many MS patients. Its efficacy is such that copaxone can be considered nearly a placebo on comparison. Your wife is one of thousands who is evidence of that.
I have pretty much given up following ELN after it was forced to sell on the very cheap half of its alzheimer program. Has there been any development in identifying markers to identify those patients at risk for PML?
Tinker
If Teva can get away with using developmental patents, as long as they do so ex-U.S. and then after development re-engineer the production process, and then import into the U.S. what has effectively been done is the destruction of any developmental patents in the United States given the global nature of the economy.
I have never litigated this issue, or studied it actually. But it is not difficult to see that this destroys the entire patent system in the U.S. that requires a patent to be published in such a manner that anyone learned in the art can read the patent and learn from it and utilize the patent.
Because of this, developmental patents would then become mere textbooks for the competition and become WORSE THAN NOTHING, because not only would they be unenforceable in any practical sense, they will also not only communicate but actually teach the competition how to take advantage of all your hard work and intellectual property. Might as well just open up the store for every competitor in the world!
Given this result, it is difficult to see how a court would allow this sort of exception to IP protection. It destroys the entire system.
But it is a clever argument and legal parsing. Wonder if there is any precedent for it. MNTA's legal team I'm sure is well versed in this, AS IT IS THE BASIS FOR THE BULK OF MNTA'S PATENTED IP! and pretty much destroys the current business model if this exception is allowed!
Am I being too dramatic here? I've only quickly come in and browsed a few posts, but came upon that legal argument. If I am reading it in context, that legal argument, if successful, destroys MNTA's business model.
Tinker
Angiomax, chemically, is a synthetic congener of the naturally occurring drug hirudin (found in the saliva of the medicinal leech Hirudo medicinalis).
Yes, off the top of my head;) Does not sound dissimilar to lovenox actually. It might not be so easy to genericize without MNTA like technology.
Does anyone know if angiomax has similar complexity to lovenox? Pig, leech, don't see much difference. Both biological. One from intestines, the other from saliva. At least it is not from the saliva (or derivative thereof) of a certain poisonous lizard, which may make another nice generic target in 8-10 years.
Tinker
Craig Wheeler stated on multiple occasions that he was frustrated by M118 partnering negotiations
If MNTA had a good and reasonable suspicion that tLovenox would be approved, and then did not disclose this to investors on their secondary, that to me would be materially misleading and most likely an actionable security fraud.
I have to conclude then that MNTA has no reasonable suspicion, anymore than anyone else of anything going on at the FDA other than what is said in its lawsuit, and what has been otherwise made publically available.
This does not change the fact that MNTA is probably prompted, in large part, by the real possibility that they want the money now, just in case, as they don't know any more than we do. And just in case, they want the money. So it probably signals nothing new other than MNTA does not know anything more than we do, and MNTA is not certain of anything, even if they have reasonable confidence.
I also think that MNTA planned all along to do a secondary after mLovenox approval. Think of it, as a corporate strategy why would you not want to raise money after a significant share price rise. MNTA could not know that the share price would fall dramatially so quickly after reaching brand new highs.
To sell securities to beat a tLovenox approval, without disclosing this strong and reasonable suspicion is just too blatnatly misleading. I therefore don't see how MNTA can have any material information that t-Lovenox approval is imminent, anymore than we do. They just don't know, but they listne to Teva rhetoric as well. No matter how self-serving and deceptive it may be, even MNTA can experience "angst" and want to raise money just in case.
I do think if the secondary goes off at a good price, then that confidence by institutional investors, who presumably have more "inside" perspective on the t-Lovenox issue, will be a positive stock catalyst.
Tinker
That questionable lawsuit would seem to give MNTA cover for this offering. After all, Teva's going to launch any day...
however, if MNTA had an M118 partner in waiting, it would have made more sense to announce the partnership first and then raise money. Hence, I don’t think MNTA is raising money for M118, specifically.
YMI!
That is the one! That is the counter example to EXEL. I forgot their name. They are the example of promising, too good to be true phase III results from post hac analysis, good enough to obtain a special and abbreviated FDA protocol, only to see such data, that looked amazing, to collapse when put into a randomized trial with pre-determined end points.
YMI is my cautionary cancer drug company. They are still at it. Maybe they will get one this time.
Tinker
http://www.marketrap.com/article/view_article/91118/howard-schers-campaign-against-dendreon
For those who want a background on this Dr. Scher and his involvement with Provenge and DNDN.
I don't know Dr. Scher, but I remember him very well. Some have called him a scumbag and worse. I have no fond memories of him. I had no problem if his complaints and issues were legitimate, but they were not. Looking at the totality of his behavior in the Provenge saga, he was motivated primarily by financial and personal interests and was not objectively advocating against Provenge in any good-faith manner.
What that means for Exel, I don't know. But Dr. Scher has a history of being a promoter and not someone who would give me any confidence in regard to anything he may represent, as what he is going to represent will only be consistent with his own interests and not that of a concerned doctor and developer of oncological treatments.
As for the other doctors on the panel, it is not unusual in high money drugs for such doctors to be involved in this sort of fashion. If this drug works (and durability is the key element missing, and that element may only be months away from revealing itself) the share price apears to be on the low side.
Check out VRTX's chart from say mid-2004 going forward. In 2005 (if memory serves) the shares started their spike from around $10-$11 into the $30s and low $40s based upon phase I data of the drug that would become known as telaprevir. I waited until $13 as I wanted some more confirmation on the drug. With some durability evidence EXEL may follow a similar pattern. Whether or not the returns hold long-term is another matter. But as you may also see from VRTX, once the shares peaked in the $30s and low $40s all the great returns were then squeezed out except if you traded in and out of the multiple subsequent fear realted troughs. I was fortunate in doing so with their largest drop back into the teens.
Point being, I think you really have to be in earlier rather than later with a drug like this as the Street will start to project the share price to maturity if the drug really starts to look like a winner, and it will start to do so very quicly. After that all the returns, except for trading on steep troughs may be gone.
However, it is usually worthwhile to wait until you know the drug really works, and you know the drug works well. The problem in this case, once the durability evidence comes out the shares are likely to spike before one could start buying. VRTX gave a great opportunity to start buying very cheapl ased upon the fact that telaprevir worked very well, and you knew it. I don't know if EXEL will give us that chance to buy cheaply if you wait until durability data is makde known - which does create some issues if you want to minimize your risk factor. But who knows how it will come out in the end in regard to share price behavior.
That is my experience in situations like this. I look forward to reviewing the slides and listening to the conference and judging for myself. 19/20 bone scans. The numbers are bigger from the usual miracle cancer drug (except for one that I remember from this company who was buying up Cuban drugs, but their numbers were not on pre-defined end points and involved some intense data mining, and the follow up phase III busted, can't recall the stock and drug now, but we have discussed the company on this board in the past).
Tinker
Functional patent on generic lovenox?
And what if the head to head trial results showed that T-Enox was superior to Lovenox?
It seems to me that the best way, and most direct way, for the FDA to defend itself in this matter is to make public the deficiencies in Teva's application. The FDA does not normally issue rejection letters for ANDAs, but it can do as it did with the immunogenicity issues in 2008, and issue a letter indicating the defects. Teva can then pervert the press to argue that "chemical sameness" is all that should be necessary for any generic, no matter how complex, except for Copaxone, which is of course a special case drug, that can only have a generic with clinical trials.
It is speculation, but from an institutional perspective you resolve the issue of the bureacratic nightmare that Teva is complaining about, and fully inform the world as to why Teva's application was not approved, and it had nothing to do with MNTA assisting in an emergency to save lives that no one else in the world was qualified to assist in saving.
Institutionally, that seems like the appropriate response. But that is just speculation, but would be something the FDA could do to create more "transparency" in its decision making, and to reduce the time that companies are left waiting in bureacratic limbo, particularly when an ANDA clearly falls short of the standards set.
It is a much better solution than the FDA arbitrarily and capriciously approving one directly substitutable generic on one standard and then on no new science or information approving other directly substitutable generics by a lessor standard.
I think in any event, the chances of actually getting information out of the FDA indicating a rejection are greater after this attack on the FDA than it was before the attack.
Tinker
Good God! Is anyone actually supporting this ARNA fantasy in the investor community? What a load of cr@p. Now, if the drug had potentially better efficacy, maybe, somehow, someway, you could hold out hope after a few more years of effort and work on the drug. But if I recall correctly this drug's efficacy was on the smallish side, at least compared to that demonstrated by its phase III compatriots including VVUS, and in comparison to the phase II drug by AMLN.
Exactly why would the FDA want to approve a minimially effective drug that has potentail fen-phen like liability issues? Why would ARNA want to, except for the fact they have no other choice?
Anyone here ever see the FDA accept pooled clinical data to prove something that one clinical trial itself could not prove?
Maybe, but I've never seen it.
Tinker
<<<What is their reasoning for misrepresenting the status of Lovenox?>>>
To keep their share price up. If Teva can get generic lovenox approved, then there really is nothing special about what MNTA did, now is there? If Teva cannot get generic lovenox approved, then dang, perhaps MNTA really does have superlative and unique technology that can just as easily take apart copaxone (counter to Teva's fervant hollering to the contrary).
The longer they can keep the share price up from copaxone FUD, the better it is for Teva. Generic lovenox itself is material, but nothing stupendous to Teva in the long-run, but MNTA's abilityt to recreate copaxone is earth shaking to Teva. The longer they can maintain the fiction that MNTA has done nothing special, the better it is for the share price for investor's being told left and right by analysts and Teva that the copaxone threat is no biggy.
Thats my initial thought on it.
Tinker
Down to the state of journalism again, but not one mention of the fact that MNTA (An American company) has raised the bar in the quality of generic that is possible to be created as MNTA has created a precise copy of the name brand drug, and insured its quality to at least the same standard as the name brand drug, whereas Teva (an Israeli company) is trying to push onto the market a generic knock-off lovenox that is not really the same, and which could endanger the health and welfare of patients.
The way the article reads you'd think there was no difference between the applications.
Tinker
If you want to label it, it is an outright bull market over the last 100 years.
http://bigpicture.typepad.com/comments/2005/12/100_year_bull_b.html
Just depends on your time frame. It is an incredible bull market over the last 100 years, but that may be interlaid within a secular bear that we never broke out of.
Tinker
<<<You have to be kidding, right? Copaxone has to be among the most sophisticated drugs I know of, both in terms of its composition and its mode of action.>>>
But Teva did not develop it, and Teva has not developed any significant drugs in over 15 years since copaxone obtained U.S. approval:
http://en.wikipedia.org/wiki/Glatiramer_acetate
That is simply not Teva's business, to develop complex, sophisticated drugs. That is not a slight against Teva, it is just not their business and their core competencies.
Teva admits that themselves from their won web-site: Proven Success - We're building on our successes in developing proprietary therapies such as the blockbuster COPAXONE® and AZILECT® - the rights to both of which were acquired from renowned institutions.
Now that Teva has tons of cash to burn, they are trying to morph into a more standard R&D sort of company, mostly by acquiring such targets I would imagine. But since 1996, I am not aware of any branded Teva innovator drug?
That was my point.
Tinker
No, not at all. Rather, I’m challenging RockRat to explain why he finds it unfathomable that Teva could have behaved in a manner similar to Amphastar and HSP.
Dew,
I'm not sure if your math bears out on that. Although I suck at complex statistics. Each individual count is not correlated with any of the other individual counts, so 40% for one count and 5% for another count cannot necessarily be added up or combined to increase the chances of success. They each stand independently. There are 4 shots on goal, each with an individual chance of winning that is uncorrelated with any of the other shots on goal. If you take their average you get:
40/100, 30/100, 10/100, 5/100 = 85/400 = 21.25% chance of prevailing in total.
However, that is not very meaningful as there would be a 40% chance of prevailing on the first shot no matter the smaller percentage on the remaining shots, and a 30% chance on the second shot no matter the higher percentage of the first shot and lower percentage on the next shot, and so on. Having more shots on goal does not necessarily increase the odds of succeeding in total, although it does give another shot on goal.
Somneone who actually understood statistics better than I, please let me know if my math is wrong on this or not.
Thanks.
Tinker
Dew,
After taking a fresh look at it. You are correct, that is exactly what Teva was stating that Marth was trying to convince listeners that the involvement of OBP means sameness has been established and hence the review of the ANDA by the Office of Generic Drugs (OGD) is complete
Here is the primary statement again from Teva:
We recently met with representatives of the FDA to discuss the status of our ANDA during the meeting we confirmed that our version of generic lovenox meets the FDA's criteria to demonstrate chemical sameness and accordingly that data related to immunogenicity are currently under review at the office of biological products."
Thanks for the link HattieTheWitch.
The comment at 57:05 was that "we do know that we have established sameness {and the application is with OBP}."
It really is the same as the first comment. At a minimum Teva is saying they know from their own sources, inquiries, information, that they have sameness. They are not saying that the FDA has confirmed for them they have sameness. But then again, they are stating this beyond they "believe" they have sameness. Which is a step more certain.
All in all, this parsing of the language in this matter is becoming less persuasive. "We know" is beyond "we believe" which is the term they were previously using.
Sometimes if you need to think too hard about something, perhaps you have to think so hard about it because you are trying to get at something that is not there, or cannot be gotten at.
Here, sure, there is some ambiguity, but I would say the trend is favoring Teva as they have moved beyond "believe" into "we know".
Tinker