Many posters on this MB are concerned about transparency and the "fall out" from the lack of same. Lets look at the last 90 (plus days).
Whitless anounces that an additional 61 clinical sites are involved with the CLEAR-108 trial, but never updates the information on ClinicalTrialDOTgov (still not updated since July 11, 2012). Is it because the FDA also announces that it is going to be monitoring that site for accuracy of statements? As a result Longs are left to wonder about the credibility of the statement and why such an important clinical achievement goes unsubstantiated.
The INSM secures a "line of credit" to make up for the $25 million impairment charge. Presumably this is going to ensure funding for Arikace going forward to commercialization, but the reason is not clearly stated at the time the loan is made. Clarification was important, particularly in view of the continued blather from certain posters about Iplex rising from the ashes. This technology is now completely outlicensed and investors can only look to Premacure (possible investment if they go IPO) and/or PCUT for future preclinical and clinical developments for this product. Issue clearified by first CC by Lewis.
Then all of a sudden, Tully steps down. More questions. Not really clear to Longs.
Then a presentation by Whitless is cancelled due to ??? (fallen arches!?!) Admittedly there was a transition in progress and the exit door was opened. Probably because of the stutter step caused by all four clinical trials being placed on "Clinical Hold" in August of 2011.
Then Whitless is out with a substantial golden parachute and Lewis is in with a substantial "signing bonus." Understandable but only a very few even suggested that Whitless was a problem.
Then additional stock is issued, awarded and/or sold. Not sure about the timing but the NASDQ says the event did not conform. More $$$ to get Arikace to commercialization? Probably.
Then LaBella gone with a golden parachute. Long overdue bacause you cannot convert a "medical device expert regulatory officer" into a "drug expert regulatory officer." I was there when Biopure tried and watched the "would be blood substitute expert" get totally lost in the process of trying to re-educate himself as to what constituets a drug. Hint, you can misuse a medical device, but you cannot overdose or underdose a patient with a device.
Then we get the CC from Lewis that 300 patients have been enrolled in CLEAR-108. Good news on that announcement.
But upon reflection . . . was the clinical milestone actually a Tully, Whitless, LaBella accomplishment? One that was not verified in transparent fashion? Do Longs believe that the INSM management changeover was necessary if the "Three Stooges" had just kept up with their paperwork? And made a few announcements? It is clear that they lacked the credibility to just say, "We have done this. We know what we are doing. Trust me." Trust went out the window back in 2009 with the blown Iplex MMD trial.
So lots of recent changes. Probably more on the way. But if Lewis hits a NTM milestone, do you think he is not going to make a statement to investors?
The next change I expect is the CLEAR-108 info to be updated and the "missing 61 clinical sites" documented and the study becoming designated "Active, Not Recruiting." These two updates will show that INSM management is paying attention to important details as far as Longs and investors are concerned. Updating this information will also demonstrate that the FDA concurs with the updates per their new website monitoring responsibility.