Phone
Acknowledgement
10 business days
EA Therapies for Single Patient

AVTX-801
AVTX-802
AVTX-803
AVTX-002

EA Policies for Single Patient

Avalo will consider requests from licensed treating physicians for access to investigational products in development for patient treatment purposes on a case-by-case basis.

Treating physicians interested in potential access to investigational products may request more information by contacting Avalo via email at expandedaccess@avalotx.com. Please note that only requests submitted by treating physicians will be considered.

Receipt of a request for information will be acknowledged within 10 business days.

Some of the factors that will be considered upon receiving a request include:

  • Whether the patient has a serious or life-threatening illness
  • Whether the patient has undergone standard treatment without success or there is no viable alternative therapy
  • Whether the potential benefits of the experimental product will outweigh any potential risk to the patient
  • Whether the patient is ineligible for or is unable to participate in a clinical trial for the investigational product
  • The impact of providing access to an investigational product on the development program for that product
  • The impact of providing access to an investigational product on the available inventory and supply for that product

Avalo’s decision on whether or not to grant expanded access to the investigational product under an Expanded Access Program should be communicated to the requestor within 15 business days of receipt.

Application under this policy is not a guarantee of access to any Avalo investigational drug. Avalo reserves the right to revise or revoke this policy at any time.

Additionally, Avalo reserves the right to deny any request at it’s discretion.

Decisions for expanded access will be made on a fair and equitable basis for each investigational therapy. Each disease we are studying may have different specific criteria due to the differences in urgency and known data on safety and efficacy.