beaver - this is the 2nd time you've used sales in a PE computation - $720M of sales would not translate into $14 of earnings per share - you're ignoring all the expenses of manufacturing and distributing the drug, let alone all the R&D, executive and admin costs.
Why does neo have so few brain cells but posts hundreds of inane messages? What's that all about?
bergy - I admit I don't read every word you have written, but you spend an awful amount of time explaining or rationalizing posts that you have made earlier because someone misinterpreted your post or didn't catch your meaning. So, when you explain that I missed the point because your post wasn't even in the context of Etep or Drisa, when the whole point of this MB and the bulk of the recent threads are all about Etep vs Drisa, really? Perhaps you should stay more focused and be more careful about what you post instead of blaming everyone else who misses your point. "Seriously", what is the point of posting something on this board if it is not in the context of Etep's clinical value?
How does $500M of revenue translate into $11 per share of earnings - it cost nothing to make the drug, not to mention all the ongoing R&D and administrative costs?
It is surprising the premium is that high for a December call - there is a greater risk of having no announcement by then vs having a negative trial result reported, IMO. Perhaps they are counting on the gradual run-up and that the shares will be closer to $10 by December, whether there is an announcement or not?
What a clueless statement - injection site irritation not a "meaningful" side effect. Irritation or inflammation of the injection site is a sign the body is reacting negatively to the substance being injected - inflammatory responses can lead to serious auto-immune complications in the long run. For a drug that must be taken for the rest of the patient's life, how could that not be "meaningful"?
The PR said they withdrew the preliminary B- rating on their proposed $225M notes issue, which was not completed and they also withdrew their B "long term corporate credit" rating, so I suppose that refers to existing long-term debt?
By broker is Fidelity - other than a couple sentences about the withdrawal, they provide no other information on why or other factors. I think this is standard procedure for a company that is late with audited statements, but I'm not sure?
When did I say "Perhaps it is a confirmatory trial" - what am I supposedly confused about or what is so unclear about the point I am making. With respect to your point about free drug providing the ability to enroll a trial, that may get you some patients on the margin, but it is not going to cover the 80+ patients needed - remember, they have to fall into a specific age category and level of disease progression. SRPT management spoke at length about the challenge of filling their 80-patient trial - it would be impossible if either drug were already available.
Drisa is a small part of BMRN - I'm not familiar with what is going on in the rest of their portfolio, but I know it is extensive - equating their recent stock performance to the prospects of Drisa is a stretch.
Frankly, I think BMRN was just paying lip service to the idea of running more trials to appease the analysts - they admitted they have absolutely no "plans" in terms of trial design, size, endpoints, etc., so to say the have plans is giving them too much credit - that was my point and I'll say it again, they don't have a chance of enrolling them if either drug is already approved.
It's all spelled out in the June 25th press release - they have filed in EU and expect a CHMP decision within 150 days, then it takes 3 months for final approval. They have not filed in the US - they are having a "pre-NDA" meeting with the FDA later this year and hope to file shortly thereafter?
bergy - You are missing the distinction - BMRN has already run their Phase III trials and they are filed their NDA for full approval (not conditional). Theoretically, the FDA could approve it with the requirement that they run a "post-marketing/Phase IV" trial, but presumably they are smart enough to know that it would be almost impossible to enroll that trial, especially if Etep is available. Regardless - the bar for full approval is higher than for conditional/accelerated approval, which is what SRPT has the opportunity for - accelerated approval requires that a Phase III/confirmatory trial already be up and running by the time approval is given, so the bar is set lower, because the FDA knows that additional data will become available down the road. They have no such assurance that BMRN will ever be able to provide additional data. Those are the rules of the game - how the FDA uses the rules when it comes to the AdCom deliberations, let alone the approval decision, who knows?
I lost track of your posts - what am I supposed to be seeing? When you say BMRN is being "smart" by not starting a confirmatory trial, I think you are giving them credit where none is due - they have no plan on how to prove that their drug is effective. If Etep's confirmatory trial is successful in showing dystrophin production and a 6MWT benefit, it will be game over. How will BMRN ever be able to recruit patients? They'll be stuck with an inferior label - one which can't be overcome with marketing muscle - the DMD community is very small and educated.
They already ran their pivotal/Phase III trials and they failed. Per their last earnings call, they have had no discussions with the FDA about the design or requirements for of any confirmatory/Phase IV trials. As jrrt posted about earlier this week, once a drug is approved, recruiting patients for a clinical trial in that drug becomes very difficult - if Etep is approved, BMRN would have no chance of recruiting any patients into a confirmatory trial.
What AF fails to point out is that theoretically, SRPT has a much lower bar to clear, given that they are filing for conditional/accelerated approval. BMRN has made it clear that they aren't running any confirmatory studies, so they have to rest entirely on the data in hand, which is weak, at best. If the FDA accepts the biopsy data as confirming the presence of newly produced dystrophin, then between the pulmonary data and the patient reported outcomes, how could they not conclude that there is a "reasonable likelihood" of clinical benefit.
jrrt - The recruiting issue is an interesting one - the sad fact is that some families may not have insurance and the only access to the drug may be through participation in a clinical trial. I can't imagine the FDA (in the face of a positive AdCom decision) would delay approval in order to force parents into participating in the confirmatory trial?
bf - I thinking you are giving the FDA too much credit. They don't have the balls to to take a stand - if they did, they would have kicked BMRN's NDA to the curb, where it belongs - no dystrophin data, failed primary endpoints and clear safety issues. As much as I would like to believe their filing of SRPT's NDA is a sign that they are coming on board, I think they (again) don't have the balls at this stage to take a stand on Etep - they will push that responsibility to the AdCom. Ultimately, between the new dystrophin data and the AdCom results, I hope the FDA is left with no choice, as we have seen that when it is not spelled out for them, they tend to mess it up.