Replies to post #135466 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

Past FDA CNS trial guidance has been a failure . We believed Dr. G. when he said these new guidelines were going to be changed. When???? What method/trials/examples will be used to validate the new guidance process rules? What confidence levels should we expect? Are investors supposed to continue to follow a CNS trials process that is clearly a failure or should we just buy lottery tickets instead?

We expect A2-73 to be effective and to see efforts going into V&V. Continuing to throw our investment money, time, resources and patient lives into the current FDA CNS hopper is just dumb. Precision medicine pharma trials are a step in the right direction. The FDA needs to do what it said it was going to do.

If we do not push for effective use of resources, who will?

[bas2020]

I read boards of many biotech but not one has as much discussions on fda guidelines etc - most of the companies are moving forward with their trial plans and starting trials on times. Only on this board, the fda upcoming guidelines and fda changes are used as excuses for delays in trial starts.

Huh? If others are starting trials "on time", then there is no one to blame!

However, I will wager that any other company that is planning to utilize the ACTC for its trials, will have its schedule affected by the newly adopted program.

All other trials, outside of the ACTC, will be self-funded. $$$

[kevindenver]

Sure companies can and are proceeding with trials designed to NOT meet the 21 Century Cures act. Like $GWPH for example. Look at the snails pace Epidiolex is proceeding.

All new company trials are better off to wait for final FDA guidance to take advantage of the possible accelerated approvals allowed within it.

Last I checked the new protocols are still in flux. Not excuses, just the reality of dealing with changes at the FDA.

I read boards of many biotech but not one has as much discussions on fda guidelines etc - most of the companies are moving forward with their trial plans and starting trials on times.

Only on this board, the fda upcoming guidelines and fda changes are used as excuses for delays in trial starts.

AVXL is so tiny and the trials are in so early stages that they are insignificant in overall schema of things. Also Dr M has never indicated any delays or dependencies on fda guidelines.

So IMO we should stop using it as excuses and focus on what co is doing on time and ask M why the delay? In most likely cases - there will be no answer

[Ragnaroc]

but but but 21 Century Cures Act and Scott Gottlieb and and "we got the drug" and its "God's gift to humanity" and and we are in secret negotiations with BIIB going on 2 years now and of coursre all those 375 automatic company share by plan by Missling is some kind of secret message to us, certainly garnering that from the board means something? Don't you think?

[Talon38]

Amateur, The posts are anecdotal and informed conjecture on most boards. I think that this board has more DD than most. That said, looking at message boards does note equate to knowledge of what companies are doing in drug development vis a vie the FDA new trials guidance. Timing is a factor; do you not think Biogen would have delayed the 2700 participant P3 for Aducanumab 18 months ago if their was an opportunity to run a significantly smaller precision medic trial. The fact that they have so much invested in time, money and corporate prestige tells you that momentum is why they continue down the dubious amyloid plaque/tau path.

IMHO, Nueren's almost 1 year delay between the end of their P2 and the yet to start P3 for Trofinetide for Rett Syndrome is connected to the FDA's new precision medicine guidance.

I say looking for the most advantageous circumstances regardless of a little delay is good management, don't you think?

Talon