The company has developed a biomarker blood test to predict a patient's response to CF101 in order to provide more personalized medical treatment. I believe this test was made available in the current quarter of this year. Also, the company is supposed to report Phase II study results of CF-101 for treating glaucoma in the 2nd Quarter. Why can't the company apply their biomarker test for CF-101 when selecting candidates for their clinical trials? This would weed out the ones that are not responsive to their medication.
My thinking here is that since EDAP is a $3+ stock at the moment with a very small market cap, it shouldn't take much to increase the company's market value within a reasonable timeframe.. Holding some key ultrasound patents would do much to accomplish this objective and could make the company an attractive buyout candidate.
Anyone read the article in today's (3/12) WSJ regarding the use of ultrasound in treating Alzheimer's Disease? Although it's still in the lab-testing phase, the researchers stated: "Our study highlights the potential of [ultrasound] treatment as a therapeutic approach for AD and possibly other diseases involving protein aggregation." I've read several other studies which discuss the potential of ultrasound in treating other medical conditions. I'm not a lawyer, but I wonder if it would be more lucrative for EDAP to concentrate on getting patents approved for their HIFU treatment in addressing various medical conditions rather than conducting time-consuming clinical trials in just treating prostate cancer.
I don't think so. The problem appears to be investor confusion. The selling action is very limited (trading volume is just above average for this stock). Nothing has changed. While the company will go the De Novo route, it still is free to seek PMA approval for specific claims regarding the use of its device for treating prostate cancer. The De Novo approval will get their foot in the door, and that's a start. This should be looked upon as a buying, not a selling opportunity.
I believe some investors may not understand the following statement in EDAP's recent press release: "The agency (FDA) indicated that while PMA approval would be required for specific claims regarding treatment of prostate cancer, a prostate tissue ablation claim could be cleared via a Direct De Novo 510(k) application." More specifically, what is a "prostate tissue ablation claim" in contrast to treating one's prostate cancer? This needs to be clarified.
Most likely, the FDA advised EDAP management to go this route because it would be much faster than the previous process due to the fact there would be less hurdles to jump.
It will be interesting to see what effect the bad weather throughout the country has had on WFM's earnings. Maybe most of the bad weather effect will be in the next quarter since the latest quarterly earnings are only through January 18.
I might add that one of the biosimilar drugs in the EPRS pipeline is one for Humira, which I believe is the no. 1 selling drug in the world.
PFNX just struck a deal with Hospira. The stock was up $1.68 today at its high. EPRS is the next one to move higher, in my opinion.
I checked about 15 biotech stock quotes a few minutes ago--booth small/medium and large cap. All were down by quite a lot. It looks like biotechs are in a corrective phase. Could be some nice buys in the near future.
The President's current Budget submission proposes to cut spending on federal health programs by about $400 billion over the next decade. Most of the resulting savings would come from reducing payments to providers, especially pharmaceutical companies. I'm not sure how this will affect the cost of some high-priced drugs sine the Budget does not propose cutting individuals' health benefits. How will providers and pharmaceutical companies compensate for these reductions?