Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Yes, they distributed a dollar-denominated capacity figure. Never said they didn't.
The blogger accused Dendreon of releasing sales figures, which they have not (emphasis added).
Almost every company I've ever asked has told me the dollar figure of their manufacturing capacity. Other analysts have said the same thing (I've talked about this very issue with about half the analysts covering DNDN). Granted, it is usually "we can address the entire $XXX million/billion market place with this mfg process", which is a little different.
And I didn't say they haven't disseminated dollar figures. I said they have disseminated figures for maximum capacity of their facilities.
Let me see if I can explain this because there is a TON of confusion about this out there.
Dendreon has a per-patient price range in mind. At the lower end of this price range, their maximum capacity for their mfg plants is $1.5B. At the highest end of the product pricing range, the maximum capacity of their mfg is $2.5B.
Let's say they price at the minimum. Dendreon will have capacity for $1.5B in sales. This does not mean their sales forecast is $1.5B. It does not mean they will sell $1.5B.
For example, Dendreon could sell $500M of Provenge from manufacturing plants capable of $1.5B in sales. The remaining $1B in capacity could be for future products or maybe they just screwed up.
Dendreon needs multiple manufacturing locations for logistical reasons, so there is a reason to build multiple plants OTHER than to handle 100% of market. Three locations makes it less likely weather is an issue. It allows fail-over redundancy. It allows for a bigger window for things to go wrong with regional mfg centers because they will serve doctors in close proximity. It allows the company to meet peak demand spikes even though average demand will not be equal to full capacity.
I think worries about passing manufacturing are not in the drama queen bear category. I think you're flat out wrong, but there are many more moving parts than the typical biologic. Since manufacturing was a significant part of our first three meetings with the company, we've had a decade to become familiar and comfortable with it.
The CMC issues were minor (documentation, equipment barcodes missing) and would not have held up approval.
Dendreon released the total number of possible patients, a rate limiting manufacturing range, and a graph showing how other first-in-class biologics ramped in their first couple of years of sales. They have explicity NOT released pricing data, except to say it would be comparable to other biologics with similar life extension.
There are people who can make educated guesses (some of us more educated than others because we know the right questions to ask), but they haven't done anything almost every other biotech has done.
There's lots that can go wrong with any drug launch. The wreckage is considerable for dev-stage biotechs trying to transition into operating companies (really ANY company trying to make that transition). I just don't happen to believe manufacturing problems will be an issue for Provenge.
Most of what ends up being provocative is overshadowed by significant factual errors...
That's good news, then. I'll look forward to seeing Ratain at ASCO and seeing what he has to say about the development. I admit that still seems high to me, but the data are the data.
I would expect success rates in Phase III to start rising by mid-10s as a result.
Next up, smoother approval path and more sponsor acceptance for trials with target screening.
I forget the numerology, but that Phase III you describe was designed to be the converting/confirmatory study. Just as the randomized P3 T-DM1 versus Tykerb study would presumably be the confirmatory study for T-DM1.
I'll note you don't actually have to "design" a study to be a converting study. TMK, the SPAs for the confirmatories don't state that aspect of them as part of the FDA/sponsor agreement.
I think we'e been through this before in the thread. OOD/Pazdur have approved SPAs on single-arm Phase II trials outside of blood cancer. Ipilimumab in melanoma is one of the more obvious. What we don't have is a lot of information on whether those trials will lead to approval as most have failed. The SPA in those cases is iffy, IMO, because the FDA refuses to specify a ORR that will "guarantee" approval. They are very much, "We'll know it when we see it."
30+% ORR in BRCa patients with no approved therapy and a drug with side effects largely better that chemistry-set chemo most patients endure seems compelling.
It wasn't that the central lab disagreed, it is that there were some lab data the investigators couldn't confirm when they went to poster, so they excluded those plus patients who had not received drug or not received a second scan.
In any case, that number isn't the important one for comparison. The important one is in Table 5, the retrospective analysis of patients who were also Tykerb failures is 23.9%. This trial is also Tykerb failures.
As to whether this trial was designed to be approvable? It's a non-SPA, single-arm, Phase II trial so any argument about it not being "designed" as approvable will always have traction. The trial was created by DNA to serve as an earlier approval pathway, however. They have always said if the data are "robust" they will take it to the FDA.
Did you count trials that were randomized to different doses?
And I'd be REALLY happy if that was the true number because it means sponsors are pulling their heads out of their asses on this issue finally.
IMGN prior data
The 25-30% number is at least twice as high as any data I've seen presented for randomized P2 oncology trials. Walking through posters at ASCO or ASH I certainly don't see every third P2 poster as a randomized trial.
HEB
No, I'm only down 40% because -76 + 36 is -40.(*)
* Sarcasm, just in case that wasn't apparent...
CTEPi
I don't see any signs of intelligent decision making in a Phase II trial that does not focus on CV endpoints. There's no point in taking a CETPi forward into pivotals without that data set in hand, unless your corporate goal is to piss away $800M like Pfizer.
Only by comparison to historical statin data or comparisons internal to each arm between dosing.
The effect of CETP inhibition on cardiovascular risk has yet to be established.
In wishful-thinking land it might not have been established. In science land it has been established to not have any positive effect.
Everyone thinks of statistics as an exact science - but it is far, far from it.
Statistics is FAR more art than science. Now if we could only get Fleming and Pazdur to realize that, we might actually save some patient lives...!
Anyone following the Introgen story closely would say the same thing. They actually claimed in SEC filings they had a SPA on their Advexin trials. This was false, as I got them to admit on a conference call (the last call where they took my questions).
One more instance of the SEC and NASD asleep at the switch.
Nothing like sitting on bad news for 5 months while you do 4 PIPES
Just like Introgen. Deceive shareholders to keep the cash machine for executive salaries in operation.
MEDI did a study in kids to see how many kids who were not vaccinated ended up with antibodies to strains of test antigens in the FluMist vaccine. This was considered an ADVANTAGE of FluMist in terms of being able to create wider protection.
Whether the FluMist CAIV can be unintentionally transmitted is not the issue. It is whether such tranmissions result in clinically-relevant infection. It's been a long time since I've looked at the data, but memory serves that none of the influenza reported in these "community crossover" studies resulted from cross-transmission of CAIV.
FWIW, the nasal vaccine technology GSK now holds from their takeover of ID Biomedical is superior and doesn't have these problems. Too bad they turfed the product.
We terminated coverage of FOLD last month. Our cost basis in SGEN on the Model Portfolio is $3.88, so we're not exactly hurting... but thanks for your concern. We are up 68% on the year.
ZGEN - IL-21 - Hepatitis
My understanding is the original idea behind the development of IL-21 was for viral. Lambda turned out to be superior, but IL-21 had efficacy in preclinical cancer models so that's where they took it.
Pazdur honored. Excuse me while I hurl...
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm163025.htm
FYI, we were the 2nd (or 3rd) lowest first full year sales forecast on the Street to start, and even that was too high. Working from memory, I think we have 2009 sales forecast $20-30M right now and have had it at that level since 2008.
In the words of the immortal Inigo Montoya:
"You keep using that word. I do not think it means what you think it means."
Do they just make s**t up on this "wire" service?
Two of the absolutely worst journalism pieces I've ever seen originated on this service. The first was picked up by FT and then there is this one. The first was just laughable. This one I don't even know where to start...but I will :)
DNDN, what is the HDPC/HIPC ratio?[/]
70/30 or 65/35 depending on the sources.
For Provenge to be included in the NCCN compendium will require compelling efficacy data from at least a large phase-2 study.
Correct. And even if one believes PROTECT is of sufficient size, it won't provide that answer on an allowable endpoint until well in to next decade.
Guys who want it off label could fork over the significant bucks for it, but I doubt that will be noticeable in the overall sales figures.
The first likely label "extension" won't technically be an extension but a mention of a positive relationship between Taxotere and Provenge (along the lines of the Petrylak retrospective data from 01/02a). A prospective trial designed in 2010 and launched in 2011 could get data by 2012 (or earlier if the Cougar trial validates the CTC marker). That would likely improve sales among oncologists. If adoption among urologists is heavy, however, even this 'extension' will also not be not very significant in terms of overall sales snce most guys will have had Provenge anyway by the time they get to the uro onc.
I should note that label extensions are not necessary to get Provenge to blockbuster status in North America, IMO of course.