Well, I haven't seen Crossen's report, so I can't comment on the accuracy of what Asensio is referring to, but what exactly is there in Asensio's press release that is real, and not just semantics and ravings?
The title: "BioTime Analyst Issues False Report"
The argument over whether the bankers and lawyers said things vs. company employees saying things. Misrepresentation of uses and sales potential? Well, it's possible he may half a point here, but this is really ancient history from what I understand.
Then Asensio follows that with a true statement from Crossen's report.
Then he follows that up with usage limitations, yet doesn't indicate what Crossen has said in his report that wasn't accurate. Do we know if BioTime recommended a maximum usage to the FDA? By the way, is there a usage limit on Albumin? If not, why not? If so, what is it? We don't know what the FDA will say about dosage, and neither does Asensio.
Safety claims? Again, what did Crossen say? By the way, if Hextend is allowed in larger doses than Hespan, couldn't you infer it's safer based on that alone, irregardless of other safety issues?
Claims about market size? Hextend could surely replace the entire hetastarch market, no? So if Hextend replaces albumin at all it's expanding the market. What if you'd like to use albumin, but it wasn't available and you had to use something else and decided to use Hextend. Again, what did Crossen say? In addition, there's a big distinction between an analyst having a belief that something will happen in the future and an actual historical fact. That doesn't necessarily make anything false or improper.
Look at it this way, all health care analysts have to have beliefs on whether a drug will pass FDA approval and what the market sizes are. Are they always right? No. Big deal. Anyone making predictions are doing just that, and aren't creating facts.
Well, if Hextend and hespan are the same, why is the FDA making BioTime conduct trials and submit information instead of just letting them market Hextend?
Define a drug. A drug is any animal, vegetable, or mineral substance used in the composition of medicines. A medicine is a compound used to treat disease, injury or pain. Doesn't sound like there should be any problem calling Hextend a drug, IMO. Besides, didn't BioTime just file a New DRUG Application?
I guess if you're Asensio, you know everything, you can predict the future, and can not leave anything open to interpretation.
FWIW IMHO.
KJ |
