Biotech Values

[bladerunner1717]

Thomas,

I was wondering that myself. And does anyone know if the immunogenicity concerns of the FDA can be adequately addressed without having to conduct clinical trials? If Lovenox did have immunogenicity concerns, it could well be argued that MNTA's drug might have less immungenicity, due to less non-active ingredients--than the branded drug. But, of course, the FDA would want evidence of that and the question is again: Can the FDA's concerns over immunogenicity be alleviated by anything other than clinical trials?


Bladerunner