The last time INSMED was granted confidentiality treatment [I believe] it involved PARI technology. Thanks hounddog!
SynteractHCR provides customized Phase I through IV services collaboratively and cost effectively to ensure on-time delivery of quality data. We have been a trusted clinical trial outsourcing partner to clients for many years, and are proud to have supported over 200 product approvals since 1987. SynteractHCR manages international clinical trials and offers a breadth of therapeutic experience, much of which strategically aligns with the largest areas of clinical R&D investment, including oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory.
Master Agreement for Services, dated as of August 27, 2014, by and between Insmed Incorporated and SynteractHCR, Inc. (filed herewith).
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Wes Kaupinen of INSMED Corp Development – states in March '15 Insmed to acquire at least one external asset this year with an orphan pulmonary focus, high unmet need, dire consequence disease in a noncompetitive environment, commercial stage asset prior to launching Arikayce– hidden gem.
’This is just the beginning, from our own internal research and development capabilities we have a number of additional programs in orphan diseases that we plan to bring forward’. Will Lewis 3/24/15.
As much as I would love to hear the word IPLEX stated by Mr. Lewis, i don't think you will hear it before Arakayce approval in EU. Then.., watch out.
As an investor, you don't have to listen to the very LOUD words being mentioned abut IPLEX but on February 25, 2013 at an FDA conference exclusively about ALS, Byer’s parents testified, Debbie Gatttoni of NJ testified, Josh’s mom Kathy Thompson testified along with 12 other Americans about their first hand benefits related to IPLEX. Some of the Doctors on the panel had previously written testament of IPLEX including, Dr. Stanly Appel.
I believe their story is still being written..,
Yes, Stephen Byer who also said.., "I thought about breaking into the warehouse and stealing the drug,"
Always batch problems. Impairment costs have written the value of this product down to $0 for this 'deemphasized' Increlex fossil. Incelex can't wait to ask FDA to terminate once IPLEX comes to market IMO.
Well we are on the busy agenda..,
5.1. Medicines in the pre-authorisation phase
5.1.1. Amikacin - EMEA/H/C/003936, Orphan
Applicant: Insmed Limited
Scope: Treatment of nontuberculous mycobacterial (NTM) lung infections in adult patients and management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cysticfibrosis (CF) aged 6 years and older
Action: For adoption of PRAC RMP AR, PRAC RMP assessment overview and advice to CHMP
From the 3/24/15 investor presentation – Physicians asked Insmed if they could extend the trial past two years since nearly everyone taking it [Arakayce] had stable to better lung function after two years when the norm is around 3% annual decline even on standard care Tobi. Arikayce is also much easier compliance than Tobi. ‘This drug really works’ .., Dr. Gina Eagle [Insmed]
Dayton Wise - now at INSM - was head of commercial operations and strategy/respiratory unit at Novartis and head of US sales for Tobi [cystic fibrosis gold standard] - - he asked top pulmonologists, what is the next/exciting thing? They told him Insmed’s Arikayce and Dayton asked Will Lewis to be a part of Insmed. Now he is one of 100+ employees at INSM in Bridgewater NJ.
Yes Itd still in NJ but will make the same move as you some day. Much diffrent INSM than the combatable Sharoky shareholder meeting we had. Never better with INSM.
He also said something similiar to this.., In the next 5 years, Insmed will be the leader in pulmonary orphan disease treatments.
Will Lewis quote 03/24/15.., ’This is just the beginning, from our own internal research and development capabilities we have a number of additional programs in orphan diseases that we plan to bring forward’. - - - “at least one acquisition in the corporate development arena’ this year.