Dear Team Iplex,
Here is the briefest recap of my conversation with Dr Allan late yesterday:
1. Insmed is proceeding immediately with a Personal Physician IND (Investigational New Drug), or Compassionate Usage, program for Iplex availability by ALS patients world-wide.
2. This program is being offered after the consideration, and rejection for reasons of timeliness or other hindrances, of either "an approved drug being returned to the workplace" or a "Treatment IND". It is felt by Insmed that the prescribed method, a "Personal Physician IND", will accommodate the needs of the ALS community faster and easier for them.
3. Details of the program are being emailed directly to all patients and/or caregivers immediately. This includes both those who have contacted Insmed directly, usually to the attention of Christy O'Neal, and those whose contact information has previously been submitted by ALS WORLDWIDE or others.
4. Further information will be available on the www.Insmed.com website as of Monday, December 8, 2008.
5. The details of a physician letter that must be provided to the US FDA (Food and Drug Administration) will be linked on the Insmed website and in the individual letters being sent to all patients and caregivers whose names have been provided directly or through other channels. I am not including what I believe to be the accurate section(s) of the FDA.com website because I do not want to misstate or inaccurately misdirect anyone to inappropriate sections of a very large and complex website.
6. ALS WORLDWIDE will continue to provide either contact or organizational support to anyone in the ALS community who needs or requests that support. This can, and will, include suggested dosage information and the assistance or support of a physician who can oversee the use of Iplex in case the patient is unable to procure such assistance from their local family physician or neurologist. Please understand this assistance is in no way as an agent or representative of Insmed-it is strictly as volunteer support to the ALS community and is provided as a courtesy to an underserved patient community. There is no charge or compensation in any form.
7. A single-page letter from the attending physician will be required by FDA and its details will also be either directly stated in the Insmed website or linked to the FDA website as of Monday, December 8, 2008.
8. The results of the Italian Observational Study are not yet available. The observed patients' information is now being compared to historical placebo history for comparative understanding. This is a common technique when double-blind study comparisons are unavailable.
9. Patients from countries other than the US are advised to provide their individual country equivalent of US FDA with the same information as required by US FDA. Alternatively, their US physician representative can submit their request to US FDA if a US address is provided.
10. The final price charged for Iplex, and the method by which such charge is collected, have yet to be determined. My understanding is that "collection of money for the initial shipment(s) of Iplex will not stand in the way of its distribution to the ALS patients." I don't know how long this view will remain in effect, and because the likelihood of private, state or VA insurance coverage is always in question or even improbable, ALS Worldwide/Team IPLEX will be continuing our efforts to secure some form of corporate or foundational assistance for those not covered by insurance. We have not yet received any commitment of such participation and, as stated, we do not yet know what the eventual charge for Iplex will be or when it will be implemented.
Other points were discussed-they are either not relevant or less specific than the above information. We are traveling today through Wednesday, December 10 but are always reachable by email or cell phone. Please feel free to extract any or all parts of the above synopsis in your own individual communications to others within the ALS community.
Best Wishes,Stephen Byer
ALS WORLDWIDE is a non-profit organization that provides support to ALS families internationally
through scientific research interpretation, individual patient advocacy and community activism.