Based on the data tonight, the Phase 3 trial 600mg QD arm will be statistically and clinically relevant when all is said and done. treating 15,000 CF patients at $300k per year is $4.5B in unencumbered revenue in my book. Once VRTX emerges as an "orphan" company with that revenue stream and finally afforded an orphan premium (5-10x revenues), we are looking at a $25-30B market cap company easily. between now and then the street will slowly catch up to this realization and take vertex out of this hep c dominated penalty box of a valuation they currently sit in.
Lazard apparently initiated with a buy rating but the analyst chose to focus on (overvalue) the HCV pipeline and overlook or dismiss CF. He has it completely wrong and should do just the opposite
TSPT decides its worth it to fund the trials for Intermezzo in which case its more capital required and further dilution to us.
it decides to scrap the product entirely, and focus on pipeline? either way i see it heading further south. there could be a better point at which to enter. but until then, might as well make some coin on the drift down.
its clear FDA wanted a study to look at the inadvertent dosing and whether the new packaging would reduce this risk, not just some explanation from a biotech company as to why they should not do the study.
Did TSPT address the fda's concern of inadvertent dosing? I understand TSPT provided a rationale as to why such a study would not be useful, but did FDA agree to that??
Dont be an idiot. the FDA explicitly said: do a CV outcomes trial. do your homework, cv outcomes trials take 3-5 years and thousands of patients, you are basically trying to rule out that the drug does not increase the risk of heart attack, stroke or death, and this takes a while to show a difference.
OREX is done, as is every other obesity company b/c the FDA does not want to approve expensive drugs with big side effects for a condition that can be "cured" by people just not being lazy and watching what they eat.
CV outcomes trials are long and expensive, thousands of patients for 4-5 years. OREX is on the hook for funding these based on the deal with Takeda. With $70m in cash, stock is not worth more than that at maybe $1-2/share.
FDA does NOT want millions of people popping expensive drugs for weight loss they could achieve by changing their behavior
Strong sell imo
I’m a shareholder and I think the very fact that you’ve chosen the Four Seasons, which is one of the most posh venues in Manhattan, to me underscores the disregard for shareholder value that you have exhibited, as does your $2,000 a month allowance for your company car and the $15 million that you’ve taken from the company (in compensation) between 2004 and 2009, not even counting 2010.
And when you look at the stock you’ve seen a decline of $200 million of value since you have taken charge (seven years ago). You’ve spent $170 million in research and development, $125 million in SG&A, and yet you’ve advanced, as far as I can tell aside from Dacogen, nothing into advanced clinical trials.
Now, what you’re proposing to do is to spend $130 million of shareholders’ money to buy a business that in 11 years, as far as I can tell, has not gotten a single drug into advanced clinical trials. And in fact you’re going to be burning $15 million a year of cash. So these drugs will require tens of millions if not hundreds of millions of dollars to even get them to the market. Then there’s no guarantee…with the elderly AML clinical trial.
You’re facing a cliff in November 2013 where your revenues will drop significantly. So I have two questions for you. The first question is, what are the calculations that you have used to justify the value of this transaction?…And the second question is have you considered selling the company, because when you look at the $2 of cash and the $2 of royalties you’ll receive and the 50 cents of tax loss carryforward approximately plus the pipeline, this is a Company that probably is worth $4.50, at least, okay, plus the pipeline…Thank you.
How did Manuso reply?
He appeared unfazed. He acknowledged there were other opportunities over time to sell SuperGen, but believes the value is greater than $4 a share. Whether this suggests SuperGen received an offer at that price or higher, though, is unclear. He then maintained that, when he arrived, there were two drugs in late-stage development, which is another way of saying other prospects had existed. Drug development, he argued, is a high-stakes gamble.
As far as the spending on our parts are concerned, appreciate that this is a business that requires considerable amounts of cash.
What about his compensation and other spending? He brushed aside the criticism that a small company made a point of hosting a conference in a high-rent hotel.
As far as the cost of this venue is concerned, I would suggest that we do everything at low prices. I don’t have that exact number for you. And relative to my personal compensation it is certainly competitive with regard to the industry.
Looks like a 10% objective response rate for gatenespib as a single agent in heavily pretreated patients with 22/33 patients achieving target lesion stabilization. Results look really good?
and other good habits, such as diet, and not taxing the healthcare system by popping pills and laying on the couch to loose weight. Please, if you are in this stock for a buyout, do not waste your time, I have nothing against anyone on the board, just trying to present objective thoughts. Look at Pfizer today, they stated they are dedicated to alzheimer's, oncololgy, diabetes, infectious disease, NOTHING about obesity. there are other potentiall partners/acquirers that feel the same way. yes, there are lots of obese people but if noone is willing to pay for these drugs, there's no market! sorry for a dose of reality, only time will tell the truth