He smells trouble for a quick refile.
The conference call will be a pump parade but no one will be listening.
PFE does $1 billion in sales. Only an idiot would say its overcrowded.
I'm sticking with ADMP. I like the companies prospects for finding a partner or partners for the inhaler development.
The FDA wants clear proof to backup assertions that a specific product has been designed so that it is used correctly in all appropriate scenarios.
This may include, for example, the ability to prove that patients and practitioners can follow all steps associated with a device in the proper order and that a device comes with clear warning indicators, readouts, and instructions. A thorough human factors testing regimen would also show whether there could be any serious consequences to either the patient or the practitioner should the device be misused, as well as offer a statistical risk model concerning misuse.
This could take years depending on what the FDA asks.
pjmyers, lets throw out everything except the epi-pen which is currently a $1 billion a year product. TEVA/ATRS will be the sole generic so now you have 2 companies in the market.
I was invested in MNTA when they were the sole generic supplier for Lovenox initially. There was no price reduction or competition since the suppliers decided they could only manufacture enough product for 1/2 the market.
I imagine the market will stay at the $1 billion level & TEVA will quickly capture 40 - 50%. Lets say TEVA has $400 million a year in epi-pen sales & ATRS gets 7% = $28 million a year in royalties.
What's the value of ATRS just based on this one product? I'd say its worth at least 10 X or $280 million which is the current market cap.
The stock price may go lower but the companies worth at least $2 a share.
"The other positive development is to see how well the Herceptin SubQ has picked up in Europe in a very short period of time, so less than a year in every major market. And you can see many of these key markets in both Europe and in Latin America already have between 40% and 50% total penetration of Herceptin in the marketplace. That's both metastatic and adjuvant. I think it speaks volumes to the convenience factor for patients and the convenience factors for hospitals and health care systems. And as I mentioned in previous reports, when we see hospitals switch or, in some cases, even countries, you literally see an entire switch of the Herceptin franchise within a health care system. And remember, the Herceptin SubQ, the MabThera SubQ that we received approval for and will be rolling out have additional patents associated with these as a way to secure Herceptin and MabThera vis-à-vis biosimilar competition outside the United States in this particular case."
If the FDA needs more human studies then that's going to take at least a year. Additional drug stability info could take a few years. Don't believe anything these guys say Monday.
More data on the shelf life sounds bad.
Dimension, I haven't been able to find any companies working on clinical trials for SQ injection. Testosterone gel will go generic before QST is on the market so thats going to be the biggest challenge. The gel costs around $500 a month now but the price will probably be cut in half. $500 for QST or $250 for the gel is a tough sell.