Is INSM expected to release the dog toxicity data?
Jesse, re your -
"Fud, it won't leak. Not only that, Insmed's not going to even release the data IMO."
- I was anticipating the possibility that somebody (other than an Insmed employee) involved in the process of data analysis might tell a friend it might be a good move to buy a few shares.
But more importantly, why are you of the opinion that Insmed is not going to release the data?
From the Q1 earnings CC -
"As I mentioned above, we have started a nine-month dog inhalation toxicity study of ARIKACE previously planned to be initiated in the second quarter. We currently expect to have top line data available from this study in the second quarter of 2013."
From the Q2 earnings CC -
"With this additional net $9.7 million funding now on our balance sheet plus the remaining $10 million of the term loan from Hercules available to us at our discretion anytime between now and year end, and based on our current ARIKACE-related development commitments, we now expect that we will end the fiscal 2012 year with a cash position of $60 million to $64 million. This forecasted cash position will take us comfortably through a number of key value inflection points, including the availability of top-line data for CLEAR-108 and top-line data for the randomized portion of TARGET-NTM. And as I said earlier, we are projecting our cash runway will extend well into 2014."
While it's true there is no commitment in the foregoing to actually release the top-line data from the toxicity study, the reference to "a number of key value inflection points, including ..." carries the implication that there are more than the two mentioned. What would also qualify as an anticipated key value inflection point (during the period covered by the funding) apart from an all-clear from the nine-month toxicity study?
Btw - even if Insmed doesn't release the data, the arrival or non-arrival of a SEC filing covering a report to the FDA of complications will decide the issue by the end of June.
And imo the release of news that there were no complications in the data from the dog toxicity study would be a "value inflection point" the likes of which are rarely seen in development-stage biotechs. Usually there is the possibility of a New Drug Application being rejected on the grounds of a safety issue arising from the data from the two-year toxicity study. But that particular potential pitfall is already behind us.
Better still - under the new legislation the FDA will approve drugs targeting serious diseases on the reasonable expectation of efficacy (rather than solid proof of efficacy) provided the safety data is there.
The nine-month toxicity study was initiated last April. The data recovery and analysis with regard to the dogs not involved in the final one-month(?) off-drug phase presumably could have been initiated as early as January 1.
For anybody here adopting the 'no news is good news' stance, here's how the bad news from the rat study arrived -
"The Company determined that there were findings in the interim data that should be reported to FDA, and we did this. Following FDA's review of this submission, the Agency provided us with verbal notification of the clinical hold on the Phase III clinical programs for Arikace in CF and NTM."
Pretty much you made the case: Insmed by not releasing any news about the dog study would be in effect reporting that the study was unproblematic. As long as there's no more clinical halts after we know the study is finished, all Insmed has to do is mention on a conference call that the study was a success. I doubt they will PR it.
A case of "no news is good news" perhaps, but good news in the form of a confirmatory PR would be even better news.
I'll be bitterly disappointed if the data is clean, and Lewis doesn't seize the opportunity to increase shareholder value with a PR to that effect.
When a stock is included in a Russell Index - the higher the market cap on the last trading day in May, the greater the stock's weighting within the index. The greater the weighting, the greater the amount of shares the tracker funds automatically buy.
One of the more interesting insights from the recent presentation was the response of Lewis when asked if he was concerned about a multi-cycle study with off-therapy periods of only four weeks producing adverse effects not seen in the multi-cycle study with off-therapy periods of eight weeks. It sounded to me as though the idea had never crossed his mind.
If the more-conservative institutional investors see a potential all-clear from the dog toxicity study as the FINAL hurdle on the safety side the price is likely to rocket with a PR confirming an all-clear. I could easily see such a PR driving the price over $50 in a matter of days. I don't know by how many multiples that would increase the accumulation by the tracker funds, but anybody holding shares before that all kicked off would be in for an exhilarating few weeks.