Replies to post #112235 on Anavex Life Sciences Corp (AVXL)

[Talon38]

Agree with you Xena although I would call the FDA transition a remold into a more efficient and less risk averse organization. Lot of shares changed hands today and i think many will "read and weep" over the next few weeks. Think RMAT and "repositioning".

[Amatuer17]

Why blame FDA?

Any trial for new indication even for existing drug needs filing of IND - this application needs to include trial Protocol and few other details.

To design the protocol - co needs to define the optimized dosage - to define the optimized dosing - they need pk/pd data.

Once company files the IND - they should get response in 30 days from FDA else they can start the trial.

If you look at the cycle - the pk/pd data is an important milestone - most of the small biotechs announce availability of this data.

Also Dr M has said repeatedly that pk/pd data is a key milestone.

Company has not announced the submission of IND - which nearly every biotech small or big announced using a PR.

AVXL has not done it - nor they have announced pk/pd data.

So rather than blaming FDA - ask company if they got pk/pd data? Have they submitted IND? Will they announce these steps?

I have sent queries to company and have received absolute no response.

So the silence to means that these key steps have not been performed and we all are waiting for any word -update from company.

[roygbiv]

Simply put - the FDA is in organizational chaos. Shorts and MM's know that this won't be cleared in the next 30 days. 60 days if we are lucky, and we may be because I believe that ANAVEX will be on the top of the paperwork pile due to the millions of healthcare dollars that it will save the federal government.

Xena- Please further explain what you mean here.