What are they going to do - have a nice supply of little blue tabs sitting on the end of a plastic stick on the edge of each patient's bed? Get real Brunoq. Try to think this through logically. But don't feel bad about it. Howie and Pam haven't figured it out either yet. They just know that Zalviso is dead in the water and need to turn ARX04 into a 60m units a year winner - peak sales of $1.2b at $20 a pop right? That has to be the biggest con ever spouted by a Nasdaq company.
It looks to me like ACRX have given up on Zalviso and are now trying to use ARX04 for everything. That of course will require new trials - oh they didn't think of that. So now we are back to this crazy notion of ARX04 being administered to patients by nurses on an as required basis. So much for self administration. Back to the drawing board Howie.
But ARX04 isn't being sold as a replacement for the morphine pump so this analysis is totally meaningless. Zalviso is supposed to be the replacement for the morphine pump and ACRX has never given us any comparables on costs between the two. With the money they are having to spend getting the Zalviso dispenser and software fixed, the unknown cost price of the units, the Unknown selling price of the units, the unknown cost of the pack of little blue tabs - it's all very well telling us what a morphine pump costs per patient but when you can't say what the alternative will cost what's the point?
Oh it must be about the start date of the new Zalviso trial right? Surely the EU manufacturer has sorted out the dispenser and software glitches by now. After all it is years since the CRL and ACRX have had nothing better to do with their time than sort out these minor glitches. But sadly not. It's all about how cheap the little blue tab on the end of a plastic stick is relative to a quick morphine injection. Oh no it isn't. They are comparing it with a morphine drip. Why are we comparing ARX04 with a morphine drip? Heavens knows.
How do you know that Herceptin SC is the Haloised version? We know that Roche are looking to DIY it on SC so this probably isn't the Haloised version. Just because that's what you'd like doesn't make it a fact.
So they said. But I've never believed a single word Baxter\Baxalta have ever said. IMHO they did the deal with HALO to stop us developing HyQ ourselves or with others. Gammagard has no patent protection so was a sitting duck to be targeted by the big boy generics. Now what are we left with - no sales and no ability to do a deal with others. Perfect says Baxalta. Did we learn nothing from the Hylenex fiasco with Baxter. Shards of glass in the vials!!
We seem to be making painfully slow progress on all the post Baxter and Roche deals. Additional Roche and Baxalta are making painfully slow progress on the approved products (other than SQ Herceptin in the EU). Baxalta are a complete waste of space and Roche seemingly isn't interested in promoting SQ Mabthera in the EU or applying for US approvals.
FOTD - what do you make of the bleeding PEG/Keytruda halt? What change to the protocol would you expect? For a drug that causes clots in the PC trials and has to employ LWH to counteract this the protocol change isn't exactly obvious.
So seemingly the market is concerned about the ADCOM. Shares down since the announcement. I can't really see why.
Fezz tweeted yesterday that Roche was a step nearer to using HALO for a SQ version of Perjeta on the grounds that they are just starting a Phase 1 trial with their own SQ version. When Roche built their new SQ facility they said that they would be producing their own SQ drugs (not just Haloised versions). I'm not so sure that the new SQ Perjeta is good news for HALO - if anything it's bad news as Roche and other big pharmas may be getting on track to produce their own SQ versions of their blockbusters. Shire are doing that with Cinryse, which was being trialled with HALO before the FDA put a stop to the trial - twice - titers!
Yes so third time around you have to fancy their chances of getting Remoxy approved. But if they do will they find a licensee or a buyer? The problem is that the new safer Oxy has now been established for so long that it will be tough to make serious inroads into their market. A few years ago everyone hated it but now you rarely hear any moaning. Clearly PTIE can't go it alone so my money would be on a quick buyout but only at about $5 with maybe a CVR of another $2 if things go well. I detest Remi and his team and it'll be interesting to see what rewards they give themselves for getting Remoxy approved and for selling out or licensing. Large comes to mind - they are an exceptionally greedy bunch. And that nice Dr Freedman - well how he never got prosecuted for selling millions of dollars worth of shares just days prior to the CRL when the PTIE was privy to the negotiations between the FDA and King (or was it Pfizer) is one of the wonders of corporate America.
Well I see the so called new groundbreaking news, which is actually very old news, has gone down like a lead balloon. When is the next catalyst Fezz? I can hardly wait.
Well apparently ARX04 is going to have peak sales of 60m units per annum of the little blue tab stuck on the end of a plastic stick at $20 a pop - must be including street corner sales because hospitals aren't going to buy it. And Zalviso - well we don't know when Mrs Murphy and little Jonny will be back in action cleaning up the little blue tabs from the floor as the new EU dispenser and software system still haven't been sorted out. It's only been years since the CRL so we can't expect miracles from our moronic Board. I can't wait to hear about ARX02 and ARX03 and ARX05.