Anavex Life Sciences Corp (AVXL)

[F1ash]

What else could the hold up be? Trial design? What is the logical explanation for the hold up?

“Clinical holds may be issued for Phase 1, 2, and/or 3 studies due to the following reasons:

human subjects being subjected to unreasonable and significant risk of illness or injury

the clinical investigator is not scientifically trained or experienced to conduct the study

the investigational brochure is misleading, erroneous, or incomplete
the information presented in the IND application does not sufficiently address the risk to the participants of the study

the protocol is deficient on design to meet its stated objectives”

“Moving to get an IND off of a clinical hold can be challenging, as the issues are often complex and reflect qualitative arguments about benefit-risk, nuances in clinical study design, the practical operational effects of trial changes, and more. Commonly, sponsors placed on clinical hold also damage their credibility with the FDA if the proposed trial design was inadequate in some meaningful way. Time is always of the essence, sponsors need to (re)initiate their studies, and they need to reestablish credibility with the Agency.

Camargo has helped a number of sponsors facing clinical holds issued by the FDA. For example, when a sponsor was issued a partial hold for not providing sufficient information to assess human risks to human subjects, the sponsor engaged Camargo for help. Camargo requested a clarification of the clinical hold immediately after receiving the hold. The company then submitted a complete response letter addressing the FDA’s concern. This resulted in the FDA removing the clinical hold, and allowing the sponsor to proceed to clinical studies using the investigational drug.”

“Camargo has long recognized the value of carefully crafting clinical study protocols to anticipate and address the FDA’s potential concerns, and has deep expertise in developing study plans that the FDA considers appropriate. Camargo also engages with the FDA in Pre-IND meetings to proactively address any potential questions or concerns. This step helps ensure a successful IND submission, as; the reviewers will have become acquainted with the product and proposed study plan; Camargo will have posed and received feedback on key questions; the Agency will have signaled any concerns; and study design discussions took place in person. Such a proactive approach is prudent and a recipe for success.”

https://camargopharma.com/2017/09/navigating-clinical-holds/

If asking IR about the Rett delay, imho the key question to ask is, “Has Anavex submitted their “complete response letter” yet”?

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