Genta Incorporated (NASDAQ: GNTA) announced today that it has initiated the clinical program for its second investigational drug, gallium nitrate. The new trial focuses on patients with low- or intermediate-grade non-Hodgkin's lymphoma (NHL) who have low blood counts and who have failed prior chemotherapy and rituximab (Rituxan®). The trial, which will be conducted at several academic medical centers in the U.S., opened at the Medical College of Wisconsin in Milwaukee. The Company filed an Investigational New Drug Application (IND) to address this new indication with the Food and Drug Administration (FDA) earlier this year.
Genta Incorporated (Nasdaq: GNTA) announced today that the Company has received notice that GenasenseTM, its lead anticancer compound, has been granted designation as an Orphan Drug from the U.S Food and Drug Administration. The designation applies to the Company"s application for such status that was filed in March 2000 for treatment of patients with advanced malignant melanoma, the indication in which the Company launched its first Phase 3 trial. Orphan drug status provides for a period of marketing exclusivity, certain tax benefits, and an exemption from certain fees at the time of submission for marketing approval of a New Drug Application.
GNTA has definitely redefined the term "orphan drug" lol
of course it's not all IMCL, but you can bet a huge chunk of it is. What fool pays the premium price LLY agreed to when their current partner with the most to lose is 10% below that? Desperate is not a good place from which to bid!
The pipeline may look good now, but the science is moving forward at such a pace that no product, even if it eventually reaches the market, will have the kind of market dominance seen in the past. Over 60 VEGF targeted compounds are in development today.
Score, Ichan =1, LLY = 0
Didn't these fools learn anything from watching BMY spend a $B for rights to IMCL products? Sorry, but you are toast on this one.
Hello McFly, the GNTA study did not compare Genasense to Campath, so your point is completely irrelevant. Of course you already know that, don't you? I don't know how you can sleep at night. What a deceiver you are!!
You omit the fact that FDA analysis of the PFS data called its validity into question due to sloppy trial management and data collection. So even if the endpoint seemingly met the criteria of statistical significance, FDA has the final ruling on whether the results are valid. If they don't believe the results are valid due to data corruption, it doesn't matter how many zeros you got in the p value. Corruption and Ray W. in the same company, is it possible? Oh my!! BTW for losers come lately, buybio is a complete loser, if you take advice from him, you will be very sorry.