You write more in a week that I write in year and I am in this board incessantly?? That was funny, thanks!! :D
Ok, I will play: What did I say that made me call liars to the management?? All my sentences start with "I give it 0%...", "I think that...", "This is why I expect...", and "In my opinion..."
Do you mind to put in words what you think that the management said in the call about Apaz??
Btw, not that I don't think the management have a long list of lies upon them, should I make a list with numbers? You seem to like those...
Other question: How many shares do I need to have so you care about what I say?? 0 is not enough, right? If I keep 1 share what I say matters more to you? Or 10 shares? How many??
I appreciate the thought. Heck, I think that I take the "high path" a lot. For example, I said thank you to the following post earlier today. How would you respond?
"Apaziquone failed 2 phase III trials. A new one is requied. 500 patients enrolled, wait two years, read out, file NDA, wait for PDUFA. I assume 4 years."
Wait for the PDUFA around April 9, 2019? Really. "
Euhm, it was me who said that. Maybe it wasn't well understood so let me explain it further: I give it 0% chance that Apaziquone is approved in 2016, based on a post-hoc analysis of pooled results of two independent, and independently failed, phase III trials. I think that the new trial needs to be finished and it needs to be succesful for FDA to consider approving Apaziquone. This is why I expect an Apaz PDUFA with some chances of being approved only in 2019. In my opinion, the FDA maybe even refuses to accept the NDA if filed this year.
I said many other things in that post you partially quoted, anybody please feel free to weigh in and point out anything that I got wrong or that wasn't true, that was a lie or anything that I made up about the clinical development or the financials of the company. No name calling.
Hi Sherry! How are you doing? How nice of you that you dedicated me a post!
That was it. I am not going to waste any more time writing you. It would be ridiculous. Bye!
Joe, let's see:
-Marqibo in 2014 R&D expenses were higher than Marqibo revenues. It is dragging the company.
-Beleodaq has costed so far $60m in milestones, 1 million SPPI shares that were sold in the market, and now it brings in less than $5m per quarter. It is like a bad joke for SPPI.
-Zevalin has been dead for years. $25m was payed for the world-wide rights. Another bad joke.
-Folotyn might lose patent protection in the trial set for 2016. $108m netto payed to bring in $12m per quarter, which I find ok.
-Fusilev has just lost patent protection. I have no idea how much revenues will fall, if they even fall.
I don't know and I don't care if it will beat estimates. Analysts seem to know less about the company than me. I expect 2015 revenues to be $100m plus Fusilev revenues, whatever they are. I don't think SPPI is undervalued now. For the future:
- Melphalan might "replace" Fusilev revenues. It is expected to be approved in October.
- SPI-2012 needs to start phase III trials, enrol 1000 patients, read out, file NDA and wait for PDUFA. I assume 3 years easy. Outcome uncertain.
- Apaziquone failed 2 phase III trials. A new one is requied. 500 patients enrolled, wait two years, read out, file NDA, wait for PDUFA. I assume 4 years. Outcome uncertain.
- Poziotinib needs to finish phase II trials, decide which phase III trials to run, run them, wait for Overall Survival, read out, file NDA, wait for PDUFA. I assume 5+years. Outcome uncertain.
I am not buying SPPI. I am buying companies that are revolutionizing medicine (CAR-T), companies that cure Hep C (GILD), or that cure people with spinal cord injuries.
"Bladder Cancer has been in uncharted territory for 40 years."
And bladder cancer will remain uncharted territory until somebody discovers a drug that WORKS!!! Apaz won't be approved without efficacy and Apaz failed not one but two phase III trials trying to get that proof.
Dcaf, you get it. There is precedent for pooling results for safety but not for efficacy, and Apaziquone is approvable if and only if the RESULTS of the yet to be started new phase III trial are similar to the post hoc analysis of the combined results of the two single instillation trials. Years away.
If there is an NDA, FDA could approve Apaz at first try because it is their prerrogative but it would be a huge surprise. Anything else about this topic is selling smoke.
"2. Sandoz must WIN the Appeal or it has to pay back all $ to SPPI as it is an "at risk" launch"
And Sandoz have launched quite a few drugs at risk in the past. They would only have to pay back anything if they lose the appeal, and well, it is always uncertain what might happen, but there is already a judge that ruled in their favor, and reading the reasoning, I have to admit that I agree with the judge, and I don't think that it will be turned in the appeal, because I cannot see how.
"3. Sandoz must CUT INTO SPPI's revenues (don't know why you think this is a given in any material respect whatsoever given that Fusilev already has generic competition)"
I didn't say that at all. I actually think that shorts are overplaying the fact that there will be generic competition for fusilev, when whoever is cost concious should have switched from fusilev to leucovorin in 2013 or as soon as they could. So MAYBE there is no impact in fusilev revenues or a small one. Nobody will know until there is generic fusilev in the market and there is competition. But, I am completely sure that there will be no impact in fusilev revenues if there is no generic fusilev, so better to delay the inevitable as much as possible. That is why they filed the appeal and the request for the temporary injunction
“Sandoz Cannot Legally market and sell its untstable Fusilev version for colorectal cancer until after April 2018.”
Joe, the one and only remaining barrier preventing Sandoz from selling generic fusilev is the TRO, and unless a temporary injunction is granted, generic fusilev will be on the market in a matter of weeks. What Sandoz will not be able to do is market it for CRC, and Sandoz’s levoleucovorin will have a label that does not include that indication, but if doctors already know that they can use it and how, and they do, nothing prevents them from prescribing the generic fusilev. Afterwards, how much will SPPI and fusilev revenues be impacted, is anybody’s guess.
Of course I was asking when will it be known whether the temporary injunction will be granted or not. John.Alvato said “this week or next week” on March 9th, and “next week” on 27th March, but still no news. You said in this post that “We should hear this week”. Why did you get that from?? Or is it an (un)educated guess??
FWIW, the difference for SPPI between that injunction being granted or not, is 10.5 months of fusilev revenues, or roughly $100m, and having 2015 cash flow positive. That is what is in play.
Does anybody know if there are any news regarding the SPPI emergency motion for an injunction in either the district court or in the federal circuit?
I guess not, because we should have heard something otherwise, but is it normal that it is taking so long for an "emergency" motion to be ruled on?
" You cannot determine that greater than 90 subset was less effective than the 30-90 minute group using your approach"
Technically true. However, do you agree that the results that we don't know need to be worse than the ones they have showed? The alternative to my scenario is that the less-than-30 minutes results are worse in the apaziquone arm than in the placebo arm, so that the results in the greater than 90 minutes can be better in the apaziquone arm. And if it was so, why not showing them? And why limiting the therapeutic window in the up side for the new trial, 30 to 90 minutes?? Why not simply say, wait 30 minutes before instillation. In the first trials, apparently there was no window, since there are results even for greater than 120 minutes.
"There is no reason to believe that the 90-120 minute or the 120 minute data is less impressive. "
Ok, if a sub-set of the patients perform better than the total, it means that the complementary sub-set performs worse. By definition. Which means that the results from up to 30 minutes and post 90 minutes combined, are worse than the complete trial results and much worse than the 30-90 minutes. If we consider than for less than 30 minutes apaziquone is deactivated by blood and has the same recurrence rate than placebo... in the 90 plus minutes there was more recurrence in the apaziquone arm??
The 67% complete response rate in that other trial that you mention, it was multiple instillation by the way... Apples and oranges.
There is one thing I didn't like from the Apaziquone results that were presented: If blood was the problem, it would make sense to have a difference between 30 minutes. But why did they choose 30-90, instead of 30+ to present? Does the efficacy goes back down if the time after TURBT is 90+??
Both SPPI citizen petitions to the FDA (one requesting orphan exclusivity extension until July and other one requesting FDA not to approve Sandoz Fusilev ANDA) received response and both were denied. Can be found on regulations dot gov.
For bragging rights, I predicted as well the outcome of losing fusilev trial in a post on 18th Jan. Quite accurately I might add, I said low 5s or high 4s.
I think I was overestimating revenues when I wrote that the run rate would be $200m in that case, but I am also thinking that we will see 7s much faster than what people think
"That Fusilev and generic Leucovorin are interchangeable is debatable. "
You can debate as much as you want, but the FDA considers them interchangeable, of course taking into account the different dosages. To the point of recommending using fusilev if leucovorin is in shortage.
"With generics you have the inert form competing with the active form."
What do you mean with competing?? For all effects the non-active isomer is an impurity, and it was never proved that it caused any biological effect, either positive nor negative.
"Generic Fusilev would pose a greater threat to sales."
There is an incentive of using Fusilev, which is price, if it is reimbursed at cost +6%. Why would generic fusilev be preferred to generic leucovorin? I.e. Which market share will SPPI lose? Who would use Fusilev because of its safety profile or lack of inactive impurities, and will switch to generic Fusilev now, when generic leucovorin was available in case cost was a concern?
Furthermore, generic fusilev cannot be marketed for CRC until 2018.
"There is a generic on the market today used for same indications called Leucovorin."
Which begs the question: If Fusilev and leucovorin are interchangeable, as they are, and Fusilev was already competing well (~$25m/qt) against a generic drug, which took away most if not all of the cost-concious customers for the drug, why would SPPI would lose more market share now with the new generic? Will generic levoleucovorin be competing primarily against Fusilev or against generic leucovorin?
And, would it make a difference that the generic levoleucovorin needs to be used offlabel to treat CRC because the orphan exclusivity protection is in place until 2018?
Btw Zeus, you can guess revenue for osteosarcoma in the range of less than $1m per quarter.
No idea. I am just an european engineer. I have no idea about biology, patent law, US lower or DC courts. I just think that the ruling I read made a whole lot of sense, that the molecule and the isomer with biologic activity was known since the 50s and so, there was prior art, that SPPI acknowledged that there was previous art of processes delivering 100% purity, and what was patented (purity above 92%, but lower than 100%) was pretty obvious. It is clear to me that the patent is now, and will remain invalid, and what can hold is the orphan exclusivity, but that is far from a given. And of course, all of the other sad sad and low revenue SPPI drugs.
Joe, you are embarrasing yourself now. I just finished reading the ruling, that guess what? exists and is real. Orphan drug means nothing because there will be generic levoleucovorin in the market in the very near future, the only difference is that there will not be CRC indication in the label, but the available dosages are the ones needed for CRC and much higher than those required for methotrexate rescue. The only hope is that the FDA does not approve the ANDAs based on less safety, but for all I have seen, all citizen petitions are denied by default. People here need to adjust their estimations for the revenues of the company, leaving out whatever they thought that Fusilev would bring in. Good news is, that there are still 4 other drugs, and hopefully a 5th one before the end of the year.