Have the investors in this company really taken into account the risk of either an injunction against Express or the fact that eventually they will lose the Palmaz patent case regardless of how long they delay the outcome. The longer the delay the bigger the check written to JNJ for damages. Think about that risk combined with safety issue/failure to get FDA approval risk and you will realize a 60:1 P/E is a little pricey (i.e., essentially no upside and a big chance of a monstrous drop if Palmaz hits or FDA fails to approve quickly).
"Of course, court battles could throw this into disarray. Boston Scientific and J&J, for instance, have a patent war going, with J&J asking a federal judge to enjoin Boston Scientific from making its Taxus Express stent. If things go J&J's way in court, that could have major adverse consequences for BostonScientific. "
-By Daniel Rosenberg; Dow Jones Newswires; 312-750-4118;
The FDA will permit a product to claim a certain indication for use (e.g. stenting de novo coronary lesions of a certain size, or direct stenting, or overlapping stents) depending on the safety and efficacy data that is presented to them. But beyond permitting the product to be marketed for a certain indication, they likely don't pay much attention to how that product is marketed for that indication. If the data can be presented in a different, more favorable, light without much of a stretch, no doubt that's how it will be presented.
Look at the Celebrex info I quoted. All the marketing to physicians used the 6 month data only. Was it a lie? - no. Was it misleading? - yes. Did the FDA intervene? - no.
More disturbingly - has the revelation regarding the downside of COX-2's made much of an impact on physician prescribing? - unfortunately not. With momentum and enormous sums of money spent on promoting these drugs pandora's box becomes difficult to close.
I don't mean to suggest the drug has no place. But most physician's are probably unaware of the full data and prescribing, in large part, based on (incomplete / biased) information passed on by the drug reps.
<< I'm not sure the FDA would take it upon themselves to publicly suggest the data be presented differently. >>
if the FDA doesn't care about misrepresentation of clinical data then where are the watchdogs? if BSX is claiming that the Taxus stent can do A,B,and C things won't those claims make their way onto the labels and in marketing materials?
in other words, they may be able to hype and mislead the crowd for a while but after approval recommendation they will need to put things down in writing about what the product will do. won't this be reviewed? and won't it look funny if the product label claims significantly less than was presented at TCT or presented in other public forums?
I have a hard time believing that BSX would go too far in manipulating the data because eventually the truth will come out - if not on Nov 20 then in subsequent review of marketing materials and if not at that time then surely during the head-to-head Cypher vs. Taxus REALITY trial.
In business you can lose two thing: 1.) your money and 2.) your reputation. One can only afford to lose money.
I would prefer that BSX underpromise and overdeliver on the Taxus stent. That doesn't look to be the case.
Assuming TAXUS IV results were manipulated in the manner described, and the FDA realizes the shortcomings in the data - what then?
Would they not look at the data merely to see if the product was approvable? i.e. if the fairest interpretation of the data shows Taxus to be better than a bare express2, does it matter how much better, as far as getting FDA approval?
I'm not sure the FDA would take it upon themselves to publicly suggest the data be presented differently.
I say this largely because of what came out about COX-2 inhibitors (Celebrex and Vioxx) recently.
The CLASS study (Celebrex) published in JAMA reported only the first (more favorable) 6 months of two longer trials spanning 12 and 15 months respectively. The FDA had the longer term data, but without the persistant digging of some data watchdogs this would never have come to light.
Similarly, the VIGOR trial (Vioxx) omitted reporting overall adverse serious events to anyone but the FDA - and yet this is where the greatest criticism of the product can be found (overall adverse serious events were higher, even though GI events were lower). Again, if nobody had been digging for the data, it would not have come to light.
If manipulation is there, I don't think it's a given the FDA will comment on it publicly.
That evaluation / criticism may have to come from elsewhere in the cardiological community.
If anyone wants more detail on what I was saying about Celebrex and Vioxx you can find it at the following link.
<"Clever manipulation of the data, among a number of other tricks (now coming to light) ...">
How is this manipulation coming to light?
Is there more detailed info on TAXUS IV available than was released in the slide presentation? If so, where might I obtain it?
It is unusual, and not the historical standard for (honestly reported) DES trials like Sirius. It is a pretty clever trick on BSX's part to make the TCT data look better than it actually is. i.e., if a patient came in on day 275 after their stent, had a 70% blockage and got another angioplasty., this would NOT have been counted as a TLR or MACE at the TCT presentation. Clever manipulation of the data, among a number of other tricks (now coming to light) employed to get a "WOW" for the analysts and less informed cardiologists listening. Similar to the dishonest reporting of Taxus 2 etc. Sheds some real clouds also over the integrity of the Principal Investigators !
I don't, of course, disagree that a lower angio rate will lower TLR (and hence MACE), or that this may have been Boston's major motivation in going with the lower rate.
I am very interested in your comments on a TLR deadline. Am I to understand that if an angiogram is performed at 9 1/2 months, they would include the data point in the stats for other measures (e.g. binary restenosis, late loss etc.) but disqualify it from TLR if an intervention was carried out on the basis of that angiogram? Is that approach standard procedure for handling TLR?
It is very clear why BSX planned low angio follow up. Angio follow up is one of the most powerful predictors of target lesion revascularization in stent trials. By minimimizing follow up they greatly decrease the 9 month TLR for a big splash at TCT. This effect was likely greatly amplified by their 9 month (rather than 8 month like Sirius) angio follow up. Since angio follow up was 9 mos plus/minus 30 days we do not know how many of the 43% of angios were done prior to the 270 day TLR deadline (i.e., it is possible that only 70-80 of the 660 taxol stents had angiographic follow up PRIOR to 270 days. This may be the only reasonable explanation for Taxus 4 results which clearly do not line up with Taxus 2 or the late loss data (i.e., the data are too good, and therefore IMHO, have been manipulated in a variety of ways). The FDA however will not fall for this trickery and will look very closely at 12 month TLR and a variety of other critical issues.
It is worth pointing out that differing angiographic followup rates will produce more of a skew in diabetics than in non-diabetics.
My understanding is that (likely due to diabetic neuropathy) diabetics are less likely to experience classic angina when coronary stenosis is present.
This means that of the asymptomatic patients who are not getting a clinically driven angiogram, there will be a higher percentage of significant lesions in the diabetic subgroup. Hence more binary restenosis to pick up by protocal driven angiograms.
I just went back myself to look at the slides from New Sirius and Taxus IV for in-stent late loss in diabetics (the best number, in my mind, to compare stents in disparate studies). New Sirius reports this number as 0.23 mm but, unless I am missing it, Taxus IV doesn't report this measure in their slide presentation. I assume, since Cypher's in-stent late loss in diabetics is still less than the overall in-stent late loss for Taxus (diabetics and nondiabetics combined), that Cypher will be significantly better in this measure. I would, however, still like to know what the in-stent late loss is in the TAXUS IV diabetic subgroup. If anybody knows I would appreciate the info.
I agree with you stentomania!
If one looks at the hype that PR went on creating may be slightly overdone with nothing to follow through. We have been foretold the quarterly results, unblinding was done, FDA review date is known. The analysts, IMHO, went out of the way in making strong recommendations and some are now trying to adjust that stance like J.P. Morgan:
"Pricing issues might be more important to Boston Scientific's short-term sales success, as Johnson & Johnson has already begun discounting up to several hundred dollars per stent. In his own research note, JP Morgan analyst Michael Weinstein estimated that Boston Scientific's 2004 revenues might come in $50 million short of expectations because of the pricing war."
I am more than little concerned that from here we may see a subtle decline because there is no news left to be told till Nov 2003 and everything might have been factored in, already.
On top of everything, if JnJ gets injunction against BSX, it is going to be big trouble.
I have seen good gains. I sold half at 66.80 and I think I will watch it closely and get out before it falls below 62.