...every biotech knows you don't
dis the FDA!!!
This is why last 10Q showed a $9.1M
payment to DOJ, bringing current fines
to about $40M plus LOSS of Credibility!!!
So ITMN execs CIRCUMVENT the FDA again
and go to the EU for approval, and then
have the GAUL to expect that the FDA
accept Shionogi Trials, to save themselves the time and expense of another Phase 3.
The FDA already said ITMN's trials are
Efficacy is the key issue alright. Why did all the other human trials show very credible effect but one of the two ITMN trials did not? That is the billion dollar question. It is all the difference in the world between approval in Japan and a CRL in the US.
Fudging results has been to known to happen. But studies are repeated in house and by the competition to validate. And it is an irrelevant point here.
It was very clear from the limited data released from the Shionogi trial that efficacy was not a problem for that patient population. And equally clear from the ITMN studies that the two phase IIIs were at odds.
BTW - thanks to everyone aside from Skippy for making this an interesting thread in a sea of day trading yammering.
Skippy, you're still a schmuck - at least on this board
Good point about this not being a biotech in the traditional sense. They have historically chosen to license bioactive agents for development and marketing - some of those were biologics (Actimune).
If you found something that worked in an animal bioassay, then found that it also had activity against a currently untreatable human disease and passed safety screens, would you stop and say "hmmmm, let's look for something more potent..." Or proceed to market.
Intermune took a drug whose activity against IPF was discovered by Marnac Inc. Marnac may have been unable to do the human trials, so they licensed to someone who could and did. It was a gamble as they already had Actimune in development for the same disease. When Actimune crapped out, they moved on to pirfenidone.
IPF is a rare disease. Genzyme has been very successful in developing and marketing drugs for rare diseases. IPF has been untreatable, but not because no one has tried - anti-oxidants, anti-inflammatories, anti-endothelins have all been tested with no success. Very difficult disease to treat and study. Maybe a monopoly until viable competitors appears or the patents expire. Maybe...
As far as the sell-off of the HCV drug to Roche. They were not going to be first to the market. They may not even have the best drug or drug combo. They still have phase III studies to do. Lotta competition. Why NOT sell those assets. They can raise funding without having to go to the market for more debt.
Buy out? Who knows. Or cares at the moment.
No, he doesn't know anything about the company. But it doesn't look like it has an IP portfolio. The valuations are high for these businesses, because of value associated with an IP portfolio, which is not visible on balance sheet. You take something like DNA, it got premium valuation, because it was a well known R&D powerhouse. AMGN on the other hand has no premium Why do you think that is? AMGN is a value stock, because the IP portfolio is weak, and R&D capabilities are weak. TEVA is a better company and IP holder then "biotech" AMGN. Absence of IP portfolio affects valuation down the line.
What do you mean so? You called this a "drug commercialization start up". You don't know anything about this company. Go so some research you ignoramus.
"because they probably infringed on it in the first place for all I know."
You don't know but you assume they probably did? Do us all a favor and go play with the traffic kid. :)
"I know somebody doing IP law"
Did they tell you to short this? LOL
What are you on about? They have orphan status and have extensive patent protection for the drug through 2030. What's 20 years of a potential blockbuster drug with huge net margins worth to BP? Go do some research.
So? How much of it is SG&A vs R&D expenses. All you said is they spent a billion dollars over what they had in 10 years. How much of it is FDA related testing, and what's the amount spent on creating real IP portfolio, not protecting one compound against any possible infringement, because they probably infringed on it in the first place for all I know. That's not exactly an IP portfolio. I know somebody doing IP law, IP has an implicit value in those biotechs. That somewhat explains the valuation premium.
What I'm saying is that there are companies with IP portfolio. This one has no IP. High valuation of biotechs implies valuation of their IP. This company is not an IP company, they have one drug and no IP. It's a different class of company that is not the same as IP heavy biotechs. IP has value, and it's not really explicitly valued, but is important for M&A.