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In the November cc Dr Missling said they had already met with the EMA several times. He also reported that the EMA saw the full data and was told to apply for full approval. At that point Dr Missling said that's what they did last week. So by those words they applied in November.
Don't feel sad. Walk away.
Ha. He could short his own company for a change.
The last NT 10-Q was due to a change in accountants. So some kind of business change again.
Nail biting.
I bet the scientists doing the reviewing are in awe like the EMA.
At least that's what I like to think..
I found this relevant to Anavex having a safe drug compound - https://www.pbs.org/newshour/amp/health/fda-increasingly-approves-drugs-without-conclusive-proof-they-work
So they widely missed target sales. Could be fear-driven death does that. Thanks
CPI not as good as expected. Tanked the market.
The same with EXCELLENCE once the company engages with FDA.
I'm sure there was disappointment in the outcome. Also I bet there was a lot of excitement in the AZ P 2/3 outcome.
What your not taking into account here is AVXL board members are insiders with full access to data and planning. This gives them the ability to see much further over the horizon than shareholders. I just don't think they are complaining. If there are disagreements they will likely come out at some point.
Dr Missling did report national and international interest. Could very well be those companies george.
ABSTRACT - "A2-73 is a useful therapeutic in the treatment of humans suffering from insomnia, anxiety or agitation."
I think it's safe to say that A 273 being a non-narcotic given for use in insomnia, anxiety or agitation would add a lot of value.
Study also reported A-273 helps with sleep problems.
I blocked that immature nonsense.
Slow but sure?
Yes Dr. Missling had not yet met with the FDA, although during his last call he did say he wanted to start with the EMA first so by that it's no surprise. By the tone of his reference to Biogen stopping its Aduhelm program, he said something to the matter of now being a good time. They are now preparing is my take.
" Contingent upon sufficient funding, we anticipate that our efforts would primarily focus on advancement of our drug candidate Brilacidin for decreasing the incidence of severe oral mucositis as a complication of chemoradiation in Oral Mucositis."
Relevant Interesting read also.
Funny thing is I've been happy buying. Plan on making some good returns. Looking forward to next cc.
An all-nighter, going on on 4am now in Stockholm.
DR Missling knows they have a safe and effective one pill a day ALZ drug. Approval means Biogen's LEQEMBI program is in big of trouble. Full data will be what EMA received.
Agree, if there has been a contradiction found that showed lesser degree of efficacy a new pr would have been sent out.
Yes a signed contract must be upheld I agree. You would think with it being an automatic renewal Cummings would have even sent notice of it going into effect. It seems Leo just disregarded the contract and if so a really stupid move.
He just let it go on which is inexcusable.
He could have at least tried to negotiate an equitable resolution out of his own pocket for once.
Yes a letter and stamp would have been ideal.
Leo's seat is his lazy boy.
My hope is those open seats are for a BeaMed merger.. Leo's been quite 6 months. We'll see
Agree. Leo needs get this judgement taken care of.
I stated what's in the 8-k is a matter of record that's all. They now have two open seats.
According to 8-k Their decisions to resign were not the result of any disagreement with the Company on any matter related to the Company’s operations, policies or practices. That's a matter of record now.
They left at the same day. Maybe there is a reverse merger with BeaMed that's been discussed on this board? Services no longer needed.
Back in the fives after a two day beat down.
Definitely buying tomorrow.
A circular meeting is my guess.
The like button was very useful in elevating good posts but now there are all these stupid emojis that I can't half make out what they mean.
I would say A-371's trial design would have began soon after the Aug 7 journal press release confirming Anavex 3-71's cardiovascular safety,. These data also expand the safety objectives met in this first-in-human study of Anavex3-71, further supporting its drug development program. This has been ongoing from inception so nothing pivotal about it.
Yes those are the facts anything contrary is just noise.
George doesn't bother me but I'm not short either.
Being short keeps one up at night it seems. Not healthy
Possibly some short will to try and use it to their advantage.. We need the full AD scientific journal report for all to see plus an NDA update.
"BeaMed is on track to submit, in Q2 2024, the System for potential FDA approval via the 510(k) regulatory pathway." 5 months since last update. Ok Leo time to wake up.
So basically your another concerned short. Got it.