Hana Biosciences (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced data from its pivotal Phase 2 rALLy clinical trial for Marqibo(R) (vincristine sulfate liposomes injection) for the treatment of adult acute lymphoblastic leukemia (ALL) in second relapse. Results from the rALLy trial demonstrated compelling evidence of single-agent, anti-leukemic activity in a relapsed/refractory, heavily pre-treated, adult population of ALL patients, with a universal history of prior exposure to the standard formulation of vincristine sulfate.
The analysis of the first 56 evaluable subjects demonstrated an overall response in 36 percent of the subjects and a complete remission (CR) or CR with incomplete hematologic recovery (CRi) in 21 percent of the subjects. The estimated median overall survival in complete responders was 7.3 months. Fifty percent of the complete responders were able to receive a potentially life-saving stem cell transplant. Fifty percent of the complete responders had remission durations longer than the duration of their prior remission. In addition, Marqibo was generally well-tolerated with a low incidence of early death.
"We are excited by the rALLy trial results for Marqibo in adult ALL that demonstrate an ability to induce meaningful remissions in patients without approved treatment options," said Anne Hagey, M.D., Chief Medical Officer of Hana Biosciences. "Based on the rALLy trial data, other published Marqibo data in adult ALL, and supportive data in lymphomas and solid tumors, we plan to submit a New Drug Application seeking accelerated approval for Marqibo in 2010."
"My point, exactly" - you claim that the evidence that the company's management is lying about the prospects for approval is that they have never provided copies of FDA "minutes, letters or the SPA agreement" and when I point out that no company ever provides that to the public, you say "my point exactly"? Are you talking out your *ss, or sh#tting out your mouth?!
The company has offered no proof of any agreement with the FDA. We are only expected to trust what the CEO says is such. If this is the case, why doesn't he publically disclose any written correspondence from the FDA (letters, minutes, and SPA agreement, etc). This documentation has got to be there if there is an "agreement". There are countless examples in this sector where CEOs have made claims about agreements with the FDA which are not the case and then on judgement day, they said they "interpreted" the FDA's opinion differently.
Who's pumping - I'm simply reiterating what the CEO has said and left it hanging on whether you want to believe it, or not - we obviously know what camp you are in. If you are such an authority on "how the FDA operates", educate us all on how and why the company would plan to file an NDA based on this trial if they did not have some agreement with the FDA on what an acceptable filing would include? The premise of your statement is that the CEO and everyone else in the company is either ignorant or committing fraud against the investment community with their planned filing - what proof do you have that the company's statements are "flat out false"?
"If you believe the company's CEO, the FDA has agreed that the benchmark for proving that premise was 9 CR's out of 56 patients"
This statement is rediculous. You obviously do not understand how the FDA operates.
Stop pumping this dog up with reckless statements like this.
When we do get the fat rejection from the FDA we should all sign up for the class action suit that will follow. The companies repeated claims it reached an agreement with the FDA on this alleged "pivotal" trial are flat out false. And so are your statements.
The only thing I can think of is that the CR rate dropped off from the interim results - I think they had 10 out of 30 CR's (33%), and the 21% final CR rate represents 12 CR's, so only 2 of the last 26 patients had CR's. If you believe the CEO, the 12 CR's still beat the milestone of 9 (16% of the 56) that they agreed with the FDA, so it should not be an issue. IMO, the drug would be approvable just on the PK/PD and safety data - it is obviously a more effective and at least as safe as the FDA approved vincristine - but the FDA acts in mysterious ways?