Replies to post #83488 on Biotech Values

[randychub]

What in your mind has made the chances of rejection increase?

With plant inspections and all bases covered as far as contaminated drug, I would add that 4% to the approval side.

MNTA/NVS ANDA rejected 4% 8%

Randy

[Bio_pete]

Thanks for your and Thomas's replies. MNTA is a pretty exciting company, but the regulatory & legal hurdles are frustrating.

One of my co-workers had an emergency heart-cath this past week & ended up in the ICU after developing an adverse reaction to the anticoagulant. I haven't gotten all the details but I'm assuming they received Angiomax. Spontaneous bleeding from lungs & other organs which almost killed him.

Looks like there is plenty of room for M118 in the cath lab.

[MotionMan]

MNTA- Dew I thought you would have thought that Momenta's chances for approval in 2009 would have been greater than 24% given Wheelers recent tone and "cautiously optmistic" about approval by the end of the year comments.

With all the plant inspections complete and the FDA having everything they need to approve this product, 4 months seems ample time for the FDA to respond.

I would have thought 24% chance before Rodman and Renshaw, and maybe up to 40-50% now for the best case scenario occuring by the end if 2009. I mean the FDA has had the aplication for over three years, how much more do they need to know about the product? Plant inspections are complete and without incident. Let's go FDA!

My only concern is if TEVA also gets approval. Judging by Amphastars recent actions they are 20 points down with 5 minutes left in the basketball game.