Replies to post #826 on Insmed Inc (INSM)

[rayovac812]

Saltmountain...I wish we had the ability to recommend posts. Well thought out.... Coin? How receptive to ideas for improvements on the board, is investorshub? Small thing to ask I would think...alot of thought and time goes into posting and it is a nice to know how well others think you did/are doing. Maybe this has been covered already. Please forgive me if it has.

[io_io]

"A small number are handled under the 505(b)(2) statute which does allow for generic drugs"

I don't think this is correct. Such a drug would be "similar", but to file under 505(b)(2) the applicant company would have to submit not an aNDA, but a full NDA or BLA, meaning that he does independent clinical trials with the product, rather than depend on the trial data of the copied drug.

Such a drug is usually developed as an improved re-formulation, at quite a degree of expense (unlike the usual generics) and time, and often the intent is increased bio-availability or reduced dosing convenience.