Replies to post #151486 on Anavex Life Sciences Corp (AVXL)

[hapit]

It is back in FDA’s hands now. So even the company may not know what they will say. Once they get a green light they will announce, I am sure. Clint told me it can be next week or in a couple of weeks, so I am guessing we are back on 30 day clock again..

[F1ash]

Rett trial delay ??? Can someone please explain why it is taking this long to get the trial started ??? FDA holding this up ?? Not approving our IND? Anyone ????

Try this. Read both of the links I’m going to include. I’m gonna pull some quotes that I find relevant, but read both links for yourself in their entirety. I believe when you finish reading you will know the answer to your questions.


“Asking for FDA Assistance
Drug developers are free to ask for help from FDA at any point in the drug development process, including:

Pre-IND application, to review FDA guidance documents and get answers to questions that may help enhance their research

After Phase 2, to obtain guidance on the design of large Phase 3 studies

Any time during the process, to obtain an assessment of the IND application

Even though FDA offers extensive technical assistance, drug developers are not required to take FDA’s suggestions. As long as clinical trials are thoughtfully designed, reflect what developers know about a product, safeguard participants, and otherwise meet Federal standards, FDA allows wide latitude in clinical trial design.”

“Approval

The FDA review team has 30 days to review the original IND submission. The process protects volunteers who participate in clinical trials from unreasonable and significant risk in clinical trials. FDA responds to IND applications in one of two ways:

1. Approval to begin clinical trials.

2. Clinical hold to delay or stop the investigation.

FDA can place a clinical hold for specific reasons, including:

Participants are exposed to unreasonable or significant risk.

Investigators are not qualified.

Materials for the volunteer participants are misleading.

The IND application does not include enough information about the trial’s risks.

A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study.


https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm#The_Investigational_New_Drug_Process


“Discussion of deficiency. Whenever FDA concludes that a deficiency exists in a clinical investigation that may be grounds for the imposition of clinical hold FDA will, unless patients are exposed to immediate and serious risk, attempt to discuss and satisfactorily resolve the matter with the sponsor before issuing the clinical hold order.

(d) Imposition of clinical hold. The clinical hold order may be made by telephone or other means of rapid communication or in writing. The clinical hold order will identify the studies under the IND to which the hold applies, and will briefly explain the basis for the action. The clinical hold order will be made by or on behalf of the Division Director with responsibility for review of the IND. As soon as possible, and no more than 30 days after imposition of the clinical hold, the Division Director will provide the sponsor a written explanation of the basis for the hold.
(e) Resumption of clinical investigations. An investigation may only resume after FDA (usually the Division Director, or the Director's designee, with responsibility for review of the IND) has notified the sponsor that the investigation may proceed. Resumption of the affected investigation(s) will be authorized when the sponsor corrects the deficiency(ies) previously cited or otherwise satisfies the agency that the investigation(s) can proceed. FDA may notify a sponsor of its determination regarding the clinical hold by telephone or other means of rapid communication. If a sponsor of an IND that has been placed on clinical hold requests in writing that the clinical hold be removed and submits a complete response to the issue(s) identified in the clinical hold order, FDA shall respond in writing to the sponsor within 30-calendar days of receipt of the request and the complete response. FDA's response will either remove or maintain the clinical hold, and will state the reasons for such determination. Notwithstanding the 30-calendar day response time, a sponsor may not proceed with a clinical trial on which a clinical hold has been imposed until the sponsor has been notified by FDA that the hold has been lifted.
(f) Appeal. If the sponsor disagrees with the reasons cited for the clinical hold, the sponsor may request reconsideration of the decision in accordance with 312.48.

(g) Conversion of IND on clinical hold to inactive status. If all investigations covered by an IND remain on clinical hold for 1 year or more, the IND may be placed on inactive status by FDA under 312.45

Page Last Updated: 08/14/2017



https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.42



On or before Dec 11 2017...


We have filed an investigational new drug application, or IND, for ANAVEX®2-73 for the treatment of Rett syndrome and are currently in preparation for a Phase 2 clinical trial.

Then again in early March Anavex stated they filed an “updated IND”

I personally think that was probably their “complete response” letter because “updated IND” seems like a strange description to me. A company can ask for all the guidance they want BEFORE they ever submit the IND. Why on earth would they submit the IND if they were not ready or didn’t understand the FDA guidance documents?

If I remember correctly somewhere in the neighborhood of 90% of IND’s are approved in the first 30 days.

The child toxicity study is not something that Anavex should have discovered was necessary AFTER they submitted the IND unless they didn’t follow the FDA guidance documents or failed to ask for help if they were confused.

My suggestion would be...Next time someone contacts IR just ask them if the FDA put the Rett IND on Clinical hold.

(Yes) should be their answer.

Then ask what the specific issue is that made the FDA take that “rare” action.