Insmed President W.Lewis stated at the conference call that a mid 2014 filing in Europe was the company time line. The application review time is 9-12 months and a lag period before launch to prepare label copy, packaging."in 2 years" is their stated target. You can listen to the call on the Insmed website. The FDA is more problematic . Insmed will need money in 2014.They will file a shelf. The question is not if, but how large?
The 45-55 Million for 2013 was for NTM CF and administrative costs to run the company.If you have a source of money allocated for a CF trial in the US ,please post it.
Your comment "WL will figure out a better application for Arikace" sounds like bashing.
NTM imho is where the company will put their efforts imho..Discussions with the the FDA as commented by Will Lewis and the timing of the offering will give us clues.
The polarized extremes are chiming in. Arikace is "worth $billions" with questionable underperformance to one spumper's claims . . . and Arikace has "failed" and INSM should drop a proprietary drug rather than determine whether there is a better indication for use, method of use or both. "Ignorance and fanaticism are forever busy and need feeding." Spencer Tracy as the character Henry Drummond (Clarence Darrow in real life) in the movie "Inherit the Wind." Wind is all these two bozos have in common.
WL will figure out a better application for Arikace, or the liposome.
"Wind is all these two bozos have in common."
An interesting comment for somebody who always says so little in as many words as possible.
And your contribution to the discussion on the difference in FEV-1 improvement was every bit as useful as we've come to expect from you.
The burn rate is going to slow significantly because the $25 million projected for the US FDA CF/Pa study is on hold. The clinical trial and expenses for patient enrollment and Chiltren are minimizing. The continued expense is going to be the EAP CF/Pa which, I would guess, is going to be looked at closely at 6 month interim data analysis points. EAP studies are intended to look for trends. The hope for that study is that the FEV1 continues to stay above baseline for an additional 6, 12, 18 or 24 month period versus historic decrease in FEV1 seen in the EAP trials with TOBI. That is one possibility. But NTM, which is a market that has no competitors, is now the focus for a "universal market effort." Until some of these questions are answered to the regulatory agencies satisfaction, INSM is in an explanation mode and investors are in a hold mode.
until recent marginal data results from a late stage trial, Insmed allocated no money for a trial for CF in the U.S.They had hoped for robust data. In this sense Arikace did fail.
Adoption in some circumstances? certainly.
Market acceptance? Marginal
Investors understand reality. Discussions with the FDA and how Insmed proceeds in the U.S. will determine the dilution amount...with 24-34 Million remaining for 2014 .(see post below).....Worst case of course is the FDA mandates both a U.S. Phase3 CF trial and a Phase3 NTM trial in 2014. Insmeds dilution will be hurtful to shareholders...............Good Luck and Happy 4th !
by terry_insm • May 1, 2013 8:36 AM Flag
Facts: 34 Million fully diluted shares .......2013 starts with 72.9 Million ( ( start 92.9 M COH - 20 debt )
*****The company will add 11M to the coffers this month****** (Correction ? ? Update due soon,Thanks to accugrowths recent post.) So 83.9 Million minus 45-55 Million will be spend in 2013 . .. Ballpark and reasonable COH aprx 34 Million after the trials. eoy 2013 Source : Insmed, Inc