2nd CRL eh and in the post Rappaport era too! And no doubt their fans said that the first CRL was a soft one just like ACRX's. Getting pain drugs approved is a nightmare. PTIE got 2 CRLs too and PFE have given up on it. But PAM says it'll all be sorted by the end of Q1 but the markets don't believe her.
If and when the resubmission is made its sure to have to go through an Advisory Committee Meeting this time around. Poor Pam with her 2 pack a day habit. Being stuck in front of 15 committee members for hours will be nerve racking. Do they allow smoking breaks?
So he totally effs up but keeps his stock options until 12/31/15. The new guy comes in and gets huge stock options upon approval too. I'm a shareholder - what do I get other than dilution?
Into the 5s Pam. It just doesn't stack up with your resubmission of the NDA in Q1 fairy story. Oh all this pressure - nip outside for a quick ciggy.
They sure will. It'll run something like this. We note your suggested course of action but see that you have failed to address two issues:-
1. To provide an answer to our question as to how many little blue tabs fell out of groggy unsupervised pain ridden patients mouths during your Phase 3 trial, and
2. To provide a detailed reasoning as to why a Human Factor Test or two is likely to provide data of sufficient quality to alieviate the need for a further clinical trial.
Share price in free fall - unhealthy short position - and an unanswered FDA question. But everything's smelling of roses eh Pam even though a 2 pack a day woman like yourself lost all sense of smell years ago.
Ring ring. Hello have a nice day you've reached AcelRX and you're speaking to ex-CEO Richard King (now demoted to telephonist). Richard it's Bob Rappaport here. What's going on with the answer to our question? Good morning Mr Rappaport - let me put you through to my successor Pam Palmer. Bob gets cut off - Richard is new to the job and never was much good at technical machinery. Swearing heard at the FDA. Ring ring. Hello have a nice day ..... Put me through to Pam in God's name. Yes sir Mr Rappaport sir. Ring ring. This is Pam's office. Quick put Pam on its Bob Rappaport and he's seething. Richard I can't Pam's taking her cigarette break. Geez. Mr Rappaport sir it's Richard again. Pam I'm afraid is otherwise engaged personally doing a Human Testing Study. Can I get her to call you back. Just tell her that if I hear her say one more time that we're happy here with the number of drop outs when we don't even know the number because you don't know the number so how can we be happy with a number that we don't even know ..... Bob gets cut off.
1) this is the greatest investment since sliced bread
2) they've just killed two guys in the phase 2 PEG trial. Sell, sell, sell.
3) this is the greatest investment since sliced bread.
4) where's my cheque?
Zahnd - you said the same at 9,10,11,12,13,14,15,16, 17 & 18, didn't you? Anyway your English is coming along quite well so maybe they won't ship you back home if you fill out the forms correctly. You still have to master upper and lower case but I don't think that's a requirement of the new Immigration laws.
Oh yes you did Fez. Remember those days when you were saying that HALO was a complete disaster and everyone should get out as soon as possible as 2 people had died in the Phase 2 PEG trial. You've got a very selective memory.
"Safety data will be key here"
I don't think so. It's been superseded already by the two deaths (according to Fez) from clots in the halted Phase 2 trial. As Helen said only the other day it looks like they are going to exclude so many sub-groups from the new Phase 2 trials that the results from those will not be directly comparable with national survival statistics. That makes the data very difficult to interpret and will also require huge secondary trials with other sub-groups included. So we are looking at the next decade maybe for approvals if we're lucky. And where does the money come from in the meantime? You and me.
Has anyone other than Fezz actually said that HALO will release survival data from the Phase 1b trial in January 2015? As far as I can see the answer is no - certainly HALO hasn't said that. In my view they will just release the primary endpoint data - safety and efficacy - on the grounds that the survival data is seriously flawed.
researcher - well at your stage of life you need things to move along quick smart and you've certainly done a splendid job outlining the best case scenario. I can only assume that Pam went out for a smoke when the Board were discussing the CRL and missed the bit about the FDA's concern about how many little blue tabs dropped out of the groggy unsupervised pain ridden patients mouths during the trial. I've always been concerned about how much those staff who keep nipping outside for a quick smoke miss. I guess this must be a prime example.
I know most of you guys had Trius like me. Did you see that Cubist is being bought out by Merck. On some CVRs when the acquirer is itself bought out the maximum CVR payment becomes immediately due. Does any body have the final CVR agreement? I've just spent an hour on Google but can't find it. If you find it take a look to see whether that provision is in there.
Personally I think it's a disgrace. Giving the directors a second bite at the cherry when they already have earlier options at low prices from which they'd benefit if Zalviso is ever approved. Now they get double rewarded if it gets approved. Quite unbelievable.
What's the betting that HALO announces that the two primary endpoints of safety and efficacy were achieved and that's it? They will say that they are still analysing the secondary endpoints. I hope the long surviving non stage 4 Russians converted their roubles into dollars before they went off to represent their country in the Winter Olympics. Well ok - it was just a safety and efficacy trial after all, wasn't it? We can't really blame them. Times for athletes is tough out there. Clinical trials are the new benefits system.
The audacity of it all. Screw up the NDA, get a CRL, the share price collapses but let's give out options to the very people who screwed up at the collapsed share price. Corporate America at its most corrupt. But Researcher thinks it's great.
Sure but not so many when the share price has more than halved and we are left with hope value on a cancer drug. You know how many cancer drugs fail I presume?