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Still posted: PDUFA Goal Date of July 23, 2020
ANIP ANI Pharmaceuticals, Inc. PDUFA
When
Thursday, Jul 23, 2020
Description
2020-07-23 FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of July 23, 2020 https://www.prnewswire.com/news-releases/ani-announces-fda-acceptance-of-supplemental-filing-for-cortrophin-gel-80-uml-301039194.html
Question...
How many votes did AP hold as a BOD?
Enough to make a difference?
Could that be why he was terminated?
A deal or partnership that wouldn't get his vote?
You may want to re-check your facts...
-Insiders are not allowed to buy stock if they have material information that is not available to the public.
-Former insiders required to report sales.
Correction.. Thought you meant other part.
pull the plug ... Meaning they are going to request the meeting and continue to mo forward. If the Refusal consisted of anything they thought was not possible to resolve they would have to abort the Corti and re-strategize.
"pull the plug" .... I meant that they terminated AP prematurely thinking that the sNDA was accepted by the FDA. They terminated AP the day after they announce FDA acceptance.
AP resigned/terminated the day after the FDA accepted the Corti filing.
Has to be a link between the events... And was never discussed publicly at least to my recollection. IMO they jumped the gun with AP termination. But a deal can be subject to Corti acceptance or approval.
SNDA - PDUFA - RTF ... I don't know if the RTF after the PDUFA is a big deal or not. However I will say again that their last press release about the RTF said it wasn't anything that couldn't be resolved and they didn't pull the filing. which would suggest obvious that were serious issues.
The pusher here imo is that AP left abruptly right after Corti filing.
WHY?
When asked about partnerships or sale of company he would always squash it quickly.
In my opinion there is a M&A deal on the table that the BOD is intent on pursuing. AP owns plenty of stock and will benefit. No reason though for him to be at the helm.
Good question. My opinion is the timing strongly suggest it had to do with Corti. Has to be strategy going forward. Partnership, buyer etc...
No. They never spoke about it. Never prepared investors for it. If it was personal they would have said it. Highly, highly likely it was abrupt and unplanned.
Institutions are controlling this stock now.
They are astute blood suckers. Retailers like RJ brokers are lushes compared to them. RJ and other retail sell and institutions buy it up.
-Retail analysts are horrible. Wrong way more than right.
-Institutions make money. Period.
Agreed. The last public statement was...AP's statement that these are easily resolved matters, and that much of what was asked for was in the submission.
If there were any changes or if that was incorrect they would have to of announced.
AND REMEMBER AP was terminated/resigned after they thought Corti was accepted. Something happened in regards to future strategies of ANIP that AP didn't agree with. There is something going on.IMOP! BOD is quiet for a reason.THEY CANT BE WITHHOLDING MATERIAL BAD NEWS FROM TH PUBLIC.
June 5th!
Fact: Wall St hates uncertainty. They rather know they have cancer than that they may have cancer.
I agree the problem here is BOD communication. Everyone knows the announcement as to why AP left is BS. Add that to the current uncertainty about Corti and here we are.
-AP has always stated a 2021 bring to market date. He felt the 2020 was to ambitious.
-BOD cares about the institution. I am sure Walsh is taking calls from them.
-We will know more June 5th.
ANIP going no where until management gives...
-Clear guidance as to Corti
-More insight on what happened with AP
-New CEO
-Unexpected positive news announcement
June 5th?
I think that will be positive for the stock.
Raymond James 2021 Cort revenue from $42m to $7mm.
That is ridiculous. I would like to see his basis for that. Doesn't make any sense.
I think short term we need a new CEO and also hanging out there is the potential rescission of the refusal to file letter. AP had spoken about ANIP requesting it changed to a request for information. They didn't mention it on the cc. I wonder if its still out there pending.
@LordDarley: I respectfully disagree.
Medicaid net sales for Acthar Gel, currently contributes only 10% to total Acthar sales
The 600m is a retroactive number.
Corti is still a huge win for ANIP when approved.
COMMUNICATION AT ANIP IS HORRIBLE
Borderline negligent.
Stock is down in parts due to AP sudden termination, an interim CEO at the helm, Corti set back and overall market conditions.
BUT MOSTLY DUE TO MANAGEMENTS LACK OF GUIDANCE AND CLARITY.
They should have a cc now that AP is gone to set things straight.
This stock will bounce back but people who couldn't hold on will be forever screwed thanks to PISS POOR MANAGEMENT!
Yesterdays correlated w/ CF downgrade announcement.
Today look like RJ Maintain may have increased the volume. They have an Outperform at $49.
They need a cc next week to paint a clearer picture.
AP was respected for his conservative growth style. Something big had to have happened w/ their intended strategy going forward. Something aggressive. Downgrade yesterday, forward strategy was a concern.
The BOD has a fiduciary responsibility to do whats in the best interest of shareholders. Right now with the limited information we have it doesn't appear to be so...But there is for sure a lot of information that we don't know about...Time will tell.
Agreed. And whatever it "IS" AP is strongly against it.
Cantor Concerns...
Uncertainty around the strategy that a new permanent CEO will bring.
-BOD aware this move would bring uncertainty. Had to be a valid reason. No cause termination clears any ill actions that AP may have done.
FDA refuse to file letter of Cortrophin Gel.
-Last public announcement addressed this. Will be resolved.
Uncertainty that COVID-19 has placed on all company base businesses.
-Master of the obvious. LOL, sorry CF.
My Opinion... Correct call to be cautious. However, stellar earnings. Fundamentally strong. New CEO will come and maybe a household name from major Pharma. Also may get some M&A activity.
I agree with the market perform until we get clarity. I don't agree w/ the $40.00 price. To me its a target and not an evaluation.
LONG AND STRONG!
Hoping Monday they announce a cc w/ Patrick Walsh.
Downgrade makes sense. No detailed guidance on anything or questions session.
Cantor Fitzgerald analyst Brandon Folkes downgraded ANI Pharmaceuticals (NASDAQ: ANIP) from Overweight to Neutral with a price target of $40.00
ANYONE HAVE FULL RELEASE?
Bizarre CC ... M&A Activity?
Thinking some type of merger or partnership that AP was/is against.
Way to hush hush about Corti filing and AP leaving.
100% out of ANIP usual pattern.
Have to believe that they are speaking more in depth with the Institutions (89%).
I found this rescission. There are many. Google “fda reverses rtf”
Alkermes on Monday announced that the US Food and Drug Administration (FDA) has reversed an earlier decision to issue a refuse to file (RTF) letter and accepted for review a new drug application (NDA) for the company’s experimental treatment for major depressive disorder.
“FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued March 30, 2018 follows productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission. No additional data or analyses were submitted by Alkermes to FDA,” the company said in a statement Monday.
Hearing they will file to have this insufficient letter rescinded and replaced with a request for information letter. That would keep initial date in tack.
Apparently as they stated publicly, most of the issues are in the filing and missed by the FDA. Other issue are not significant.
The FDA is a fickle branch. Worst case Corti gets pushed out a quarter. Listen to past cc's AP always said Q1'21.
As for AP leaving... I think these are two separate events and have nothing to do with each other.
All public information and JMO.
I am long ANIP.
I see. Yes I agree with you.
I meant BOD jumped the gun by getting rid of AP before Corti approval.
Disagree
"standard technique by bureaucrats to push out deadlines to take final action"
Always a conspiracy theory. Bottom line ANIP dropped the ball. Now we get pushed out further.
AMATEUR HOUR AT ANIP.
Two years to file an insufficient sNDA.
BOD jumped the gun w/ AP termination.
Nothing to do now but hold on.
BOD has some explaining to do June 5th.
Yes. Agreed. So AP does deserve credit for navigating ANIP through that.It fails back on what happened to generate the sudden termination and also being kicked off the BOD. Doesn't make sense. Has to be some type of M&A activity that he is/was against.
First, the BOD IS HORRIBLE! ANIP is trading at 2016 levels! They haven't been able to create any returns for shareholders while making millions of dollars a year. AP deserves to be ousted.
In my opinion you are reaching here..."if a certain objective was met these things trigger". If these "triggers" existed it would have been discussed to some degree on the companies conference calls or filings. Wall St does not like surprises and the sudden departure of AP (To the best of my knowledge) was never discussed or anticipated. The timing of his departure suggests a major disagreement on what direction to take ANIP post Corticotropin or a frustration that may have been building within the BOD towards the pathetic returns to shareholders(Themselves too).
(Long ANIP)
Can you point us to were you read that?
Makes sense that their sudden no need for AP would suggest a buy or partnership. And that 10m change in control that was pointed out here, if true would be a good clue as to what may be going on.
SCHEDULE 14A
So AP will not be staying on the BOD. Looks like there was a major sudden issue(s) between BOD and AP. Upsetting is we all know the first press release of why AP was leaving along w/ the quickness of it is to be taken as suspect. I take comfort in thinking that if AP was terminated for any ill reasons it would have been w/ cause. Also the BOD owns a ton of stock, which is good for us.
The truth will come out eventually
I think if AP was staying on as a BOD, they would have said that in the news release.
The timing of this news is suspect.
My guess would be that the BOD and AP had a major disagreement pertaining to the direction of ANIP, post Corticotropin filing. We could speculate all day long.