His lips are moving..... I spoke to an underling at the law firm of Levi & Korsinsky. He explained that the options offered our CEO are in violation of our company,s bylaws. The suit would be against the Board members as individuals and not be against Insmed. I'm considering signing the retainer. I would like to hear "intellegent" reason for and against doing so.
Blasé, I somehow lost the reply button to your post so I am replying to you under my original post. I wanted to thank you for your civil and concise response to my uninformed post as to Mr. Lewis's compensation.
The answer to the question of who performed the DD and what were the findings on the safety file have never been answered. Supposedly LaBella and Glover did the DD and reported to Sharoky. Based upon this DD, Transave company was acquiered in December 2010. The bases reported were the Phase IIb CF/Pa results, an agreement with NIH to collaborate on an NTM clinical trial and marketing surveys suggesting multiple $300 million revenues. Four Phase III INDs were submitted and agreed upon with FDA in March 2011. Chiltren was hired to oversee CF/Pa studies (both US and Europe) after March 2011. Then Drucker was hired in late July 2011 and August 1, 2011 the FDA review of the preclinical safety data placed all INDs on "Hold." The FDA stopped the clinical trials because of two rats out of 100 in the carcinogenicity study with "lesions." Later Wedbrush leaked the fact that the finding in two rats was "foamy macrophages" which is a precancerous lesion in rat carcinogenicity studies, except these rats breathed liposomes daily for two years and would be expected to have "foamy macrophages." INSM management responded with a "??? scientific explanation" which resulted in the requirement for a carcinogenicity study in dogs for the NDA filing, a downgrade of the NTM study to Phase IIb, a delayed start of the Phase III CF/Pa trial in Europe to March 2012 and a $25.9 million impairment charge. Then there were costly "golden parachute" departures (Glover 2011, Tully, Labella and Whitten 2012) after all bonuses and stock options were awarded for their "underwhelming" performances. All this had to be approved by the BOD. The key question from the above timeline is "when did Transave management find out about any foamy macrophages and did they communicate that information to INSM?" Beyond that, why did the INSM DD not include direct conversations with the CROs that performed all the safety studies upon which the Phase III clinical trials were all based. Usually Phase III trials do not require any further preclinical animal studies of safety.
But if the gripe is about Lewis coming in, cleaning house and getting things done, I fail to see a problem. He will have earned his remuneration and bonuses if a statistically significant number of patients from the CF/Pa study in Europe enter the extension study and do well and sometime soon the NTM study "beats the 84 day clock" for getting negative NTM cultures from 3 ml of sputum. Those would be significant clinical achievements that would demonstrate the value of Arikace. Also, I totally doubt the dog study will show any precancrous characteristics with any foamy macrophages found in the lungs. Highly doubtful.
The only problem I see is mismanagement leading up to Lewis, but Sharoky and the BOD approved all the pre-Lewis mismanagement.
Those are the issues I see.
Red, I concur. The big question is why now? Why the "investigation" at this time. My theory is that either a former disgrunled employee is seeking some payback or a potential suitor is efforting to keep the pps as low as possible. I have seen this before. I strongly believe that Lewis has zero to do with this and that he will counter as quickly as it is prudent. Remember, the science is the science. The potential is still very positive.
Sharoky set out to see what he could afford.
Transave lay dormant for a couple of years untill Insmed came in with money.
The phase2 2009 results were looked at by those who invest in such companies?- No takers
do you really believe any biotech that could be a blockbuster potential would not attract money or interest?
Sharoky diluted old INSM shareholders by 35% and btw- that is exactly where we sit today 64 cents ! - 2 years+ after the deal.
old shareholders paid off Transave debt ,were dealt a reverese split and paid for big compensation to old and new managment.
Bringing in a hedge fund manager to manipulate the price so hedge funds - NOT Institutions- could make their cash up front and now carry no risk.
what did Sharoky see? - A chance to make a lot of money without your vote without your say.
I believe this is a credible information position in regards to the lawsuit
Could you please post the aforementioned bylaws that come into play? I would think that would help us, well at least me, come to an intelligent position.
Thanks for your work in contacting L and K.