After being on over a dozen consecutive calls, this one, IMO, was the most revealing. Whitten apparently said the heck with all of that proprietary stuff about the rat study, and described the study in detail. 120 rats, dosed at super high levels for two straight years, and two rats developed a single tumor.
Insmed took over thirty days to respond to the FDA regarding their strong scientific rationale regarding the study results. Of course rummdum says that if they would have just consulted a veterinary pathologist, it would have been no problem. Darn, why didn't Insmed think of that???
Rummdum also believes that the company should focus on NTM and have some iPLEX manufactured while forgetting about CF for now. Wait a minute... the European medicines agency is letting Insmed proceed with the CF trial vs. the current standard of care - TOBI, in what could turn out to be a type of "winner take all" trial. It seems as though the EMEA has said the heck with all of that harmonization stuff, two sick rats is not enough for us to stop CF victims from possibly getting a more effective treatment option!
Of course, the FDA is letting Insmed proceed with the NTM trial..... does that mean the FDA has determined that NTM sufferers are worth whatever risk the FDA has decided arikace presents, but CF victims are not?? The trial, however, is a phase II rather than the previously filed phase III - which the FDA had asked for!! When questioned why, Whitten basically said that he does not have a clue! The trial design is identical.
Anyway, the questionably delayed arikace trials appear about ready to get started, and if those "phase II results which generally translate into positive phase III results" prove out, Insmed should begin to garner a little more attention than it has in recent months.
Oh yeah, although not discussed on the call, Accugrowth was quick to point out that an additional three babies have been dosed in Sweden. If the original five that were dosed well over a year ago were not showing any positive results, would Premacure have begun dosing again??
You are correct, I am not new to INSM, I stumbled across it in Jan 2010, but I am not a long timer either.
<...Tully has not been known for his honesty with investors.>
Can you point to some of his dishonesty, for reference.
I did not listen to the call but I know the added trials and the 70- remaining cash will not be enough.Added dog trial added Phase two trial added time to run the company etc
Management is there to smooth over Insmeds coming weak cash condition.I don't believe a word of it.
Stu, as far as I can remember, you are not a new investor here and as far as I can remember, Tully has not been known for his honesty with investors. His numbers don't make sense. The cash amount decreased $31.8 million from the $110M they had in the bank. Plus the $4.4M they made of Iplex would put their cash burn rate in 2011 at $36M. Last two Q's their R&D and G&A expenses were running in the $10M range. Their G&A and R&D expenses are going to be north of $40M in 2012 plus the trial expenses. $78M on hand as of Dec 31st minus $40M is $38M, minus an additional $15-20M for the initial trial costs.
Tully's estimates don't take any cost of trials into consideration and assumes some kind of cost savings in either R&D or M&A.
Tully stated that COH at the end of this year would be $40MM to $44MM. This implies INSM will burn through $34MM to $38MM in 2012, this may not "make sense", but that is what was presented. I won't resort to name calling at this point, but he stated the EOY COH of $40MM to $44MM...twice.
AriKace has a good chance of hitting, but who is going to benefit? They burned through $32M last year and the cost of trials are going to double their burn rate. Now it's a certainty they will need to raise money by the end of the year and before any trial test comes out. This will be a painful one.