We plan to initiate this study in the second quarter and dosing will be completed nine months after initiation followed by a recovery period.
how long is a recovery period? second quarter could be up to five months yet for a recovery period ending June 30 2013.
I don't think that a start date was ever announced. It was just stated that the dog studies would begin in the second quarter of 2012. If we assume that they started late June, then that would take it out to the end of March. 60 to 90 days after that for results?
Insmed had a quarterly report on May 8th which mentions that the dog trial commenced already. So, April would have been the time. I see Fud posted something that April was the time......so , April 1-30 is the best I see at present without taking the time to research further.
MONMOUTH JUNCTION, N.J., May 8, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a biopharmaceutical company, today reported results for the first quarter ended March 31, 2012.
Key Recent Highlights:
U.S. Food and Drug Administration (FDA) lifted clinical hold on ARIKACE® (liposomal amikacin for inhalation) in Cystic Fibrosis (CF) patients with Pseudomonas lung infections;
Initiated dosing in CLinical Evaluation of ARIKACE phase 3 study (CLEAR-108) of ARIKACE for CF patients;
U.S. phase 2 clinical trial for ARIKACE in the non-tuberculous mycobacterial (NTM) lung disease indication on track to begin in mid-2012;
Commenced dosing for nine-month inhalation dog toxicity study.
"We are pleased FDA has lifted the clinical hold on ARIKACE in CF patients, and are excited about the important recent progress we have made with our ARIKACE development program," said Timothy Whitten, President and CEO of Insmed. "Many of the trial sites for CLEAR-108 are up and running, including those in key European countries and we are also proceeding with this study in Canada. We anticipate top-line efficacy and safety data in mid-2013. In addition, we are working towards initiating our phase 2 U.S. clinical trial for ARIKACE in NTM patients in mid-2012."
"We are at a point of significant focused activity with our ARIKACE development program, and continue to believe that ARIKACE provides a late-stage, potentially highly differentiated opportunity, with significant global commercial potential in both CF and NTM," continued Mr. Whitten. "Importantly, we believe our current cash position is sufficient to generate top-line data from CLEAR-108 and the randomized portion of the U.S. phase 2 clinical trial for ARIKACE in NTM."