crackedtooth schreef:
10k highlights
investor.insmed.com/secfiling.cfm?fil...1. Enough Inventory through 2010.
2. No outsource manufacturer identified yet.
3. 12-18 months to get approved once identified.
The transfer of the Boulder facility to Merck takes away our internal IPLEX™ production capability. We believe, however, that we have sufficient inventory of IPLEX™ to support our ongoing Amyotrophic Lateral Sclerosis Expanded Access Program (“ALSEAP”) in Italy through 2010 together with the IPLEX™ requirement for the clinical trial currently being planned with the FDA for ALS patientsin the US. Any requirements for IPLEX™ beyond 2010 or any significant increase in demand beyond our current commitments either in the Myotonic Muscular Dystrophy (“MMD”) or ALS fields will require that we identify a Contract Manufacturing Organization (“CMO”) to produce the necessary IPLEX™ to meet the demand. We estimate that the tech transfer of our IPLEX™ production process could take 12 to 18 months once a CMO has been identified.
-12/31/2008 - accumulated deficit - $346 million (ie future tax write offs)