Extreme FDA Trades: 20 Stocks Under 5 Bucks [View article]
Glad you mentioned Genta & CTIC. Both have had problems with FDA in the past. Genisense works in a subset of CLL patients - there was not a single leukemia doc sitting on the ODAC that gave it a thumbs down, and MM is a very difficult challenge, so delayed progression in a subset of patients with low LDH is progress . CTIC would like Pixantrone to be thought of as not adding to cumulative doxorubicin mediated cardiac muscle damage, but that data is probably not going to be significant. If ODAC blows off Genisense again, Genta is toast. I have to give Genta's Ray Warrell major league credit for staying with this and not abandoning ship - he could have gone back to the clinical setting at MSKCC or facsimile.
Great post! It would be quite useful if your excel file could be downloaded, then someone could sort on other attributes, or even add some, e.g. #drugs in phase 3, total #drugs in pipeline, #big pharma collaborations, PADUFA dates, if any, etc. I'm offering a few comments vis-à-vis individual companies: I think EXEL, which probably has the deepest pipeline on your list, is gaining because investors believe Glaxo will take XL647. I believe it's, "show's over", for TELK (Telcyta is finito). Onyx is declining because it faces stiff competition from Pfizer's Sutent & now Wyeth's Torisol in renal cell carcinoma. Any sales increases for Onyx's Nexavar will come from off-label use in liver cancer, but that is not, in my opinion, a reason to invest. CEGE's recent decline is a gift - when European Revlimid sales appear on their balance sheet, along with clinical milestone press releases, it'll get back into the 60's. GNTA has been on a slippery slope for some time now - their CEO, Ray Warrell, is very smart, very committed, and held in high regard by his oncology peers at his alma mater, MSKCC. He is making use of FDA's dispute process for Genasense in CLL, so some investors are betting FDA will offer up a conditional approval in subsets of patients. The key here is that CLL is a very heterogeneous disease - therapy needs to be more individualized. Finally, in my opinion, ISRG is absolutely the future of surgery. Any decline into the low 130's is a bargain. Thanks again for your article!
Extreme FDA Trades: 20 Stocks Under 5 Bucks [View article]
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