Like many of you, we were notified yesterday that the Transcon PTH clinical trial has reached capacity. We share in your frustration, heartbreak, hopelessness, and anger. We know this is especially challenging for those who went off Forteo to get into the trial, or for those who had already been approved and were anxiously awaiting their start date.
We also acknowledge that this creates an inequity, where some people have access to medication, while many others do not. We do not want those who have the opportunity to have medication to feel bad, we are happy for you. We do want those of you who do not have access to medication to know, we are here with you, and we will continue to fight to make our needs known.
We have spoken with Ascendis (the pharmaceutical company that owns the TransCon PTH study. We want to provide the following information based on that conversation:
• There were 76 openings in the trial. There are regulatory requirements regarding sticking with this number, it is not something that can be deviated from.
• They had a tremendous amount of interest in the trial and based on their predictions, they have enough people who passed the initial screening to fill the 76 positions.
• Ascendis is working to expedite the trial with the goal of having their results published by the end of this year.
• Assuming the results are favorable they would then move toward FDA approval. They are not giving any sort of timeline on that at this time but did reiterate the goal is to get it to our community as soon as possible.
• If you feel you were given a position and now feel you are being denied, please contact the location that screened you and ask for more details to determine what happened.
Ascendis is a small and newer company with 550 employees across the globe and they believe in their technology. We have a mutual commitment to remain in contact and they will keep us updated along their journey toward FDA approval.
We know for many of you, this is not the best news. 76 is a very small number for our population and many of us are struggling every day. We will continue to advocate for our community to ensure the pharmaceuticals and the FDA know the urgency of our needs.