DNDN
I'd like to ask a few follow up questions. Thanks in advance for your response.
1. Why isn't 9901 sufficient for approval? As for 9902a analysis being modified, isn't that OK if you learned something from the results? If the company used sound statistical analysis, I would think it is acceptable.
2. The delay in filing the BLA could be caused by many factors, not the least is that they were searching for the MOA. I thought management filed after discussing further with the FDA. Could the delay have been self imposed and overturned from discussions with the FDA?
3. Manufacturing capacity reduction makes sense if you are cash strapped and can expand quickly, both of which seem to be the case for the company.
4. As a CFO, you generally leave because you are shown the door or there is something wrong with the accounting policies/financial statements. I haven't seen anything on the accounting side that seems to be a problem, but we wouldn't know unless there is an internal source. Also, there is no reason to play accounting games with a pre revenue company whose fortunes rest on their product, not their results.
You may be correct, but there is just as much anecdotal support for a positive outcome as you have laid out for a negative response from the FDA. How heavily do you weigh the fact that there isn't any real downside (except cost) and there is a potential upside for people with little or no alternative?
I'd like to see more facts on the pro and con side to get a better understanding on the prospects for Provenge. Arguments that rely on supposition as to motive and rationale are not as persuasive. Like many small early stage biotech's we have fewer facts and rely on intuition to form an educated guess.
AI
