Because of the class action filing, GNTA officials declined to take any questions at the conference call. The call, which lasted about 15 minutes, provided an opportunity to review where the company is on Genasense, where it intends to go, plus some additional comments on Ganite.
They pointed out that the results submitted for review were statistically significant, but a majority of the panel did not like the results on ability to halt progression, notwithstanding testimony from patients. They pointed out that additional clinical testing is ongoing, not just for melanoma but for a large group with non-Hodgkins, prostate, and breast cancers, with most of the cost paid by Genta, and no expenses for the patients. They admitted the panel vote was a setback but seemed convinced that Genasense has good prospects.
As for Ganite, they indicated that they believe there are many possible applications in addition to hypercalcemia. Since Ganite is already approved for hypercalcemia, it may be tried in other settings as well.
As I mentioned previously on the litigation, based on my own experience and knowledge concerning similar litigation against other companies, it's not likely to go anywhere. I've seen plenty of companies engaging in real cover ups that manage to get these cases dismissed. The reason is that recent amendments to the securities laws have made it possible for a company to cover its statements by simply warning that this is the best information available at the time and does not predict future performance or future events. These "safe harbor" clauses make it difficult to prove any liability short of outright fraud (e.g., where documentation shows that an official knew something was going wrong and deliberately concealed it from shareholders).
The quality of the research here is very good. Additional research data will probably be submitted to the FDA, the FDA will at some point consider any data that would appear to contradict the advisory panel findings. FDA approval might be delayed beyond the end of the year, though with an election coming up, and with interest in the government doing its best to get new drugs approved, especially for cancer treatment, I doubt that this FDA is going to hassle anyone.
There is another factor worth investigating--the curious timing of the release of the advisory panel findings. Normally, such a public document would be released ONLY after the close of trading on a particular day. This smacks of a deliberate intent to manipulate the share price and raises questions about the integrity of the advisory panel members. Was there an intent to permit someone, either a panel member, or a friend of a friend, an opportunity to speculate on GNTA? Looking at all the scandals that have been revealed (most of them, unfortunately not by the SEC but by the New York State Attorney General), frankly I'm not surprised by any act of profiteering at shareholders expense.
Art |
