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re: Akebia Therapeutics (AKBA)- Vadadustat FDA Approved AT LAST!!

Posted on 3/29/22 at 9:34 pm to
Posted by bayoubengals88
LA
Member since Sep 2007
24743 posts
Posted on 3/29/22 at 9:34 pm to
quote:

Did they submit for two indications?
Yes. Those with anemia from CKD that are both on dialysis and not on dialysis.

The goal of the drug is to raise hemoglobin levels within a reasonable range.
This post was edited on 3/18/24 at 9:57 am
Posted by bayoubengals88
LA
Member since Sep 2007
24743 posts
Posted on 3/30/22 at 6:25 am to
Didn't think it would take this long.
You'd think a CRL would have been released yesterday if that were the case.
Posted by jimjackandjose
Member since Jun 2011
6748 posts
Posted on 3/30/22 at 8:16 am to
Stock going crash!

I always lose these coin flips
Posted by WDE24
Member since Oct 2010
54853 posts
Posted on 3/30/22 at 8:40 am to
Yeah, not getting good vibes. I sold some earlier in the week to lock in gains and thinking about getting out. The shares I still hold have a $1.91 cost basis. Can’t decide whether to settle for decent gains or hold and hope they got approval.
Posted by jmcwhrter
Member since Nov 2012
7995 posts
Posted on 3/30/22 at 8:41 am to
honestly can't remember -- is this the make or break for this company? Is there no reason to own it if denied?
Posted by WDE24
Member since Oct 2010
54853 posts
Posted on 3/30/22 at 8:44 am to
They’ve got other drugs and this drug is actually approved and in use in Japan, so it may not go to zero on denial.
Posted by Chucktown_Badger
The banks of the Ashley River
Member since May 2013
37056 posts
Posted on 3/30/22 at 8:50 am to
If they got approval the PR would be out by now.
Posted by jmcwhrter
Member since Nov 2012
7995 posts
Posted on 3/30/22 at 8:57 am to
maybe the PR guy had to stay home because his kids' school is closed for rain?
Posted by WDE24
Member since Oct 2010
54853 posts
Posted on 3/30/22 at 8:58 am to
I agree. I have sold 60% of my position this week for decent gains. Hopefully enough to protect from a loss on this if we are right.
Posted by redfishfan
Baton Rouge
Member since Oct 2015
5545 posts
Posted on 3/30/22 at 9:03 am to
quote:

If they got approval the PR would be out by now.


Not really. They have 3 days to disclose the approval. Generally speaking if they were to get a CRL or extension that would be announced sooner rather than later. Later usually means approvals but not 100%. Maybe they had a deal with a bigger company that would purchase AKBA upon FDA approval of the new drug. It could be great news it could be bad news but the fact nothing has been released yet makes me think more good news than bad.
Posted by jmcwhrter
Member since Nov 2012
7995 posts
Posted on 3/30/22 at 9:05 am to
might be waiting for a volcano or an earthquake to act as a distraction
Posted by WDE24
Member since Oct 2010
54853 posts
Posted on 3/30/22 at 9:05 am to
quote:

Later usually means approvals but not 100%.
I want to believe. Why do you say this?
Posted by Hussss
Helena, AL
Member since Oct 2016
7803 posts
Posted on 3/30/22 at 9:17 am to
The market is already telling us “no approval.” The volume with the drop says it all.
Posted by redfishfan
Baton Rouge
Member since Oct 2015
5545 posts
Posted on 3/30/22 at 9:34 am to
quote:

I want to believe. Why do you say this?


CRLs or extension are generally released before decision date. Not always but generally speaking. You can find countless examples of approvals announced after the decision date. Again, its not 100% but the majority of the time no news ends up being good news when it comes to these bio stocks.
Posted by jmcwhrter
Member since Nov 2012
7995 posts
Posted on 3/30/22 at 9:36 am to
quote:

The volume with the drop says it all.


Didn't this stock do tons of volume yesterday and move exactly nowhere?
Posted by WDE24
Member since Oct 2010
54853 posts
Posted on 3/30/22 at 9:45 am to
I may regret it, but I’ve now sold 80% of my position. I’ve made enough now that it could go to zero and I would basically break even, so I will hang on to the rest and hope you are right.

I’m wondering if there is a point where buying back in makes sense if it continues to drop with no news. $1.75?1.50? $1.25?
This post was edited on 3/30/22 at 9:53 am
Posted by Chucktown_Badger
The banks of the Ashley River
Member since May 2013
37056 posts
Posted on 3/30/22 at 9:46 am to
quote:

They have 3 days to disclose the approval.


Where did you see this?

Approval is material to the share price and withholding it for any amount of time significantly increases the likelihood of insider trading, and more importantly the clock is ticking...they want the news out there as soon as physically possible so they can get started on their promotion and leverage the approval coverage. And the FDA posts all response letters to Drugs@FDA in a timely manner to provide transparency.
This post was edited on 3/30/22 at 9:47 am
Posted by Hussss
Helena, AL
Member since Oct 2016
7803 posts
Posted on 3/30/22 at 10:02 am to
quote:

Didn't this stock do tons of volume yesterday and move exactly nowhere?


Big funds and big banks colluding? Where have we seen this before?

JPM on the phone with XYZ hedge fund: “ Ready to make some serious coin? Short AKBA while we hold the price up and wait on ya (yesterday).”

Today, all systems go. Same ole wash, rinse and repeat.

This is why I hardly invest in individual names any longer and only play market direction through ETFs. Unless you have some serious inside info playing smaller cap individual names, you are fricked!
Posted by jmcwhrter
Member since Nov 2012
7995 posts
Posted on 3/30/22 at 10:13 am to
Couldn't the opposite also apply?

"We'll hold the price down while you accumulate"
Posted by redfishfan
Baton Rouge
Member since Oct 2015
5545 posts
Posted on 3/30/22 at 10:21 am to
quote:

Where did you see this?


I could be wrong but I've seen it on stocktwits a bunch of times and nobody has ever questioned it so I assume it to be true. Could be 100% wrong though. Google didn't help me find the answer either.
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