Replies to post #347 on Insmed Inc (INSM)

[mpetisth1]

FDA agrees to rule changes allowing “preclinical” human trials
WASHINGTON - The US Food and Drug Administration (FDA) announced new guidelines for human testing that are intended to make promising drugs reach the market in a speedy manner. The FDA feels that this step is warranted since the lengthy process of approval is seeing a less number of new drugs coming on to the market.

The FDA said under the new guidelines, researchers will be allowed to give minute doses of the experimental drug to human subjects to see if the results are promising enough to warrant fast forwarding the process and thus making sense of costly clinical trials.

FDA acting director Andrew von Eschenbach said that drug development "is expensive and too often uses technologies of the last century to evaluate cutting-edge, 21st century treatments." Hence the change in rules would allow investigators to quickly analyze the effect of a compound and enable them to "more rapidly establish whether a new compound truly has a clinical benefit for people."


Health and Human Services Secretary Mike Leavitt said that nine out of ten drugs that undergo costly clinical trial ultimately fail and hence this step was designed to expedite the whole process. This means that drugs that are slated for clinical trials, but do not work can be consigned to the bin in the earlier stage itself, thus saving millions of dollars. The number of drugs that the FDA approved last year was only 20 as compared to the 36 in the previous year.

[abby3]

but when you partner, you loose the autonomy of deciding which indication to further develop, and all the potential upside gained from generating another indication on your own. aside from severe insulin resistance (which itself is a very small market), myotonic distrophy, hiv lipodystorphy are small indications which INSM can explore and commericialize by itself in the next 6-12 months. i'm not against partnering per se, just at this point; there's more upside to the stock if they show a benefit in one of these indications by themselves and could attract more value negotiating w/ potential partners down the road.
plus with its own manufacturing plant exists the potential to in-license other compounds, on its way towards building a company with development manufacturing and commnercial expertise. partner now, and what do you have to offer a potential outlicensor with no sales force to add?

outside of this, any thoughts on what happens to insmed shares if trca reports a dismal first quarter of sales? positive or negative for insm?