I have no more information than anyone else, only the one email in the 191160 post. Fortunately, the litigants will hopefully have all the information. (if you want to "cut to the chase" go to the portion right before the end of the post)
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Originally it started with a post from Closetinvestor (191160)
Which is here:
"Uh oh, NP caught telling Amarex to file the incomplete BLA no matter what:
From: Nader Pourhassan <npourhassan@cytodyn.com>
Sent: Tuesday, April 14, 2020 10:49 AM
To: Kush Dhody <kushd@amarexcro.com>; Kazem Kazempour <kazemk@amarexcro.com> Cc: Nitya Ray <nray@cytodyn.com>
Subject: BLA submission
Dear Nitya and Kush:
Today we have so far in 1 hour almost 20% drop in our stock price. Yesterday we had drop also after putting out great results about COVID-19 patients we are seeing these type of decline.
This drop will be much deeper if we don’t file our BLA as the message board now is getting bombarded by investors who are very frustrated with me and CytoDyn.
Please file the BLA no later than next week Wednesday, even if we are short in no matter what portion of whatever it is that we are short.
Dear Nitya: Please communicate with Kush about how much time they need to prepare the CMC portion after you send it to them. Kush told me yesterday he needs one week if so, they need the CMC package tomorrow to make the next week's Wednesday deadline. Please talk to Kush to see if there is any way they could take 1-2 days to prepare the CMC portion for final filling as you and I discussed yesterday
Dear Kush: The COVID-19 is no longer CytoDyn’s top priority as if the stock continues its drift then financially we will have problems financing itself. THE MOST IMPORTANT thing now is BLA. Please focus on that urgently only.
With best regards Nader" The quotation marks are mine L53
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I provided my interpretation of the email(s) [You'll notice that even though it is one email, it has separate messages to "Kush" and "Nitya", a message to "Nitya AND Kush," and the whole email has three intended recipients:
Nitya Ray
Kush Dhody
Kazem Kazempour]
My interpretation is found at post #191182
Which is here:
Interesting exchange between the Amarex folk and Nader!
(see Closetinvestor #191160)
The two excerpts below from the April 14, 2020 communication(s):
"Dear Nitya and Kush:
Today we have so far in 1 hour almost 20% drop in our stock price. Yesterday we had drop also after putting out great results about COVID-19 patients we are seeing these type of decline.
This drop will be much deeper if we don’t file our BLA as the message board now is getting bombarded by investors who are very frustrated with me and CytoDyn.
Please file the BLA no later than next week Wednesday, even if we are short in no matter what portion of whatever it is that we are short."
"Dear Nitya: Please communicate with Kush about how much time they need to prepare the CMC portion after you send it to them. Kush told me yesterday he needs one week if so, they need the CMC package tomorrow to make the next week's Wednesday deadline. Please talk to Kush to see if there is any way they could take 1-2 days to prepare the CMC portion for final filling as you and I discussed yesterday"
*****
It appears Nader believed (based on these communications) the BLA is very close to being finished. Nader is under the illusion that all that's left to do is the "CMC" portion and that will only take a week. Nader wants the BLA on the way! ...and since the BLA is essentially finished (based on his conversations with Kush/Amarex), in the event there's any minor stuff to address - they can, if necessary, take care of it later.
At least that's MY interpretation of the conversation.
Unfortunately, the BLA was VERY substantially flawed missing significant amounts of necessary information. And "one week" is total BS to completing the finalized BLA ready for filing!!
This appears to be Amarex leading Nader "down the garden path!"
There was no way the BLA was anywhere near finished!!
Nader was working under the assumption (based on the information coming from Amarex) the BLA was one week from being ready for submission. Nader wasn't personally knowledgeable or an expert on BLAs, that's why he hired Amarex to complete the BLA...it was delegated to Amarex...and he trusted them and the information they supplied to him.
Now we find out how badly he was misled and "let down" by Amarex!
Further, substantiating Amarex's perfidious behaviour - this BLA has already taken months to correct and it's going to take a few more months to complete (a bit more than the "week" mentioned by Kush).
IMO
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Whereupon Closetinvestor challenged my interpretation in his post #191292
Which is here:
“It appears NP was totally relying on what he believed to be credible information from Kush Dody of Amarex.”
Please tell me how this statement has anything to do with NP relying on Amarex:
“Please file the BLA no later than next week Wednesday, even if we are short in no matter what portion of whatever it is that we are short.”
He is telling Amarex, who he pays to be the CRO, to file the BLA even if it’s “short”, no matter what portion. He’s telling them to file an incomplete BLA.
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And my response to his challenge was post #191410
Which is here:
Return to post #191182 and the analysis of the email(s) provided in post #191160.
Again - the choice of taking a piece of the data out of context leads to a far different inference.
Reread post #191160 and it strongly appears NP was relying on Kush Dhody and Amarex to competently complete the BLA.
Nader was not the one completing the BLA - he had farmed it out to Amarex. It appears he took Dhody/Amarex at its word...as it turns out - they were not trustworthy.
Based on post #191160, it supports the contention that Nader thought (after the inclusion of the CMC) the BLA would be ready to submit. He wanted it submitted by "the deadline" and was not aware if it had any flaws that would need to be corrected, but (in his haste) he mentions submitting the finished BLA (and if there's any "minor stuff" we'll deal with it later >> the part in parentheses is my interpretation).
This is the result of his "farming it out to Amarex." Amarex, his contractor, was fully responsible for the BLA's successful completion. NP was badly misled by Amarex.
IMO
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My conclusion (remember -based on the very limited information) - I don't think Nader was aware of the "disaster" the BLA represented. He may have begun to harbor a growing degree of skepticism as to Amarex , but I don't think he had a clue as to where things really stood with the BLA. He was dependent upon Kush Dhodi, the liason (?) with the CRO for the BLA's status. It seems Kush has previously indicated (this is the email we'd really need to examine!!) in essence, 'we need one more piece.' Nader's trying to expedite getting that piece (CMC) in place so the document can be sent off.
I doubt that Nader had a copy of the BLA constantly updated in his office - it's being managed by Amarex and is in their data storage - so it can be worked on. Even if Nader had the 100,000+ page document in his office closet - would he know what he was looking at, or for or, for that matter, what the FDA would be looking for? I believe he was dependent on Dhody and Amarex, to execute this compendium. He was taking them at their word.
This email is not sufficient to make a "firm" decision - but if pressed I'd say, yes, he ordered the BLA sent off, but wasn't aware of its true state. He had only the information from the CRO to go on.
That's my view, but it's an interpretation and it would be very helpful to see what prior communications, referencing the BLA, were received from Kush Dhody.
Still, Who in their right mind would allow a crucial document, as important as a BLA, to be sent off if it was a known disaster?
Was there a frantic message just prior to the "send off" from Amarex/Dhody/Kazempour saying, "Hold off, the BLA isn't finished!" Because they were the only ones that understood how poorly prepared the BLA truly was.
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Oh, something I read tonight and I can't re-locate the information...
Supposedly the FDA set Nader and CytoDyn up with Kazempour and Amarex. That's allegedly how the relaionship started. I can't find the original statement, so cannot attest to its credibility, perhaps someone else can pop up the link.
IMO
