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   Biotech / MedicalNKTR Drug delivery Company


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To: Arthur Radley who wrote (480)8/9/2019 1:51:16 AM
From: tuck
   of 508
 
Mildly surprised no class action suit has been filed yet. But tomorrow's another day :>) :>( This is a case where one would actually be appropriate, methinks.

No position, thankfully.

Cheers (if possible), Tuck

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To: tuck who wrote (481)8/9/2019 9:01:09 AM
From: Arthur Radley
   of 508
 
Tuck,

Having now read the full transcript of the CC this fiasco is now coming into full focus. Robin admits they had noted the 'issue' months ago and were trying to figure out causation for the variance in results. So what was Robin doing during this period--unloading about $1 billion of his shares. Having participated in a clinical trial I understand the fact the patients have to sign massive amounts of release forms to be admitted to the trial. But this isn't a case where the drug was doing them harm, the issue is simply the drug companies were dosing with a drug that wasn't what they signed off for being dosed with. I just find it hard to comprehend--two drug companies with years of drug development where they were combining their respective component to make the new drug--and they had no system in place to validate the components being combined to make the new drug. HOW! Just HOW could the most critical aspect of the effort (blending the respective components to make the new drug) and they had no clue to what was or what was being added to the mix.


Furthermore, hasn't NKTR opened themselves to liability suits by dosing patients with something other than what they had signed off to use in the clinical trial. A good tort lawyer will have a field day questioning NKTR's CEO--"Mr. Robin, when did you become aware of the variance in response rates in the clinical trial patients? " Mr. Robin, why did you sell $1 million worth of your Nektar stock?" "Mr. Robin, you reported on August 8th, that you had already informed the FDA of the issue, when did you inform the trial patients they had been dosed with a defective drug?" "Mr. Robin, considering you were well aware there was a defective product being used with patients, why didn't you inform your shareholders about this issue. Don't you think a defective drug that could impact patient's life is a material event worthy of disclosure.

And one final question, Mr. Robin! "Are you familiar with Sam Waskal and Martha Stewart?"

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To: Arthur Radley who wrote (482)8/9/2019 1:44:34 PM
From: Miljenko Zuanic
   of 508
 
Arthur,

I am as much frustrated as you are, or even more...because I did try to educate myself on PEG-chemistry, how it works in conjugation with proteins and what are objective in specific drugs/target.
However,
I am short in capacity, when IL-2/IL2R interaction are evaluated.,..so, how specific pegylation of IL-2 (6-->5-->4--> 3-->2...) influence interaction with IL-2 sub-type receptors.. and hydrolysis rate and chemistry.. that dictate plasma life of the ACTIVE 2PEG-IL2/1PEG-IL2..and so many other questions.. there is no BLENDING od components....there is real science that is not easy to understand and interpret. Mistakes and missteps can be made so easily. That is why BMY paid big bucks to be part of efforts.

Now, IF it is chemistry (CMC) to blame, I am all for it. IF there is true understanding, chemistry can be fixed and bring candidate forward.
IF it is something else,.. first euforia and than reality sink in...declining activity due to *regular* nature of the drug development (selection of the specific population), than it is more devastating then first explanation (chemistry).

In all this, the tricky point is why did BMY reduced target indications? They do not need to develop and pay for development for all those 18 specific indications. If 214 can be used with any anti PD1 drug, they make money as % of TOTAL sale on 214 as well as their own anti-PD1 drug.

So lawsuit will not serve me, you or any other SH, but Robin should return his gain from stock sale, be removed as CEO, and let NEW management do their job.

Bottom line, at this point one should not be seller, maybe not buyer as well, let dust settle and see more clearly what future hold.

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To: tuck who wrote (481)8/9/2019 6:35:42 PM
From: Miljenko Zuanic
   of 508
 
<Mildly surprised no class action suit has been filed yet.>
"On October 30, 2018, we and certain of our executives were named in a putative securities class action complaint filed in the U.S. District Court for the Northern District of California, which complaint was subsequently amended on May 15, 2019. Also, on February 13, 2019, and February 18, 2019, shareholder derivative complaints were filed in the U.S. District Court for the District of Delaware naming the CEO, CFO and certain members of Nektar’s board. Both the class action and shareholder derivative actions assert, among other things, that for a period beginning at least from November 11, 2017 through October 2, 2018, our stock was inflated due to alleged misrepresentations about the efficacy and safety of NKTR-214. These cases are in the early stages. Accordingly, we cannot reasonably estimate any range of potential future charges, and we have not recorded any accrual for a contingent liability associated with these legal proceedings. However, an unfavorable resolution could potentially have a material adverse effect on our business, financial condition, and results of operations or prospects, and potentially result in paying monetary damages."

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To: Miljenko Zuanic who wrote (484)8/9/2019 7:35:08 PM
From: tuck
   of 508
 
Ah, well maybe they can amend that suit. Something to keep an eye on. Whatever the details, I wouldn't expect them to come out of this particular issue legally unscathed.

Edit: I see an "Investigation" by a law firm was just announced an hour or so ago.

Cheers, Tuck

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From: Arthur Radley8/17/2019 6:40:03 PM
   of 508
 
CFO nets another $250;000.00 by flipping a option conversion into shares and selling them yesterday.

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To: Arthur Radley who wrote (486)8/19/2019 2:43:25 AM
From: Miljenko Zuanic
   of 508
 
What a waste of the options! SUCKERS!

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From: Arthur Radley8/26/2019 6:02:49 PM
   of 508
 
Unbelievable—-the CEO dumps another 30,000 shares four days before the FDA is scheduled to meet about approving thei opoid product...the same day Oklahoma wins their case against J&J! Arrrrgh!

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To: Arthur Radley who wrote (488)8/28/2019 7:45:10 AM
From: ghmm
   of 508
 
FWIW they already announced PDUFA won't be met.
That was CFO and he exercised and held code M (didn't sell), Robins actually exercised and held the other day too
sec.gov

sec.gov

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To: ghmm who wrote (489)8/28/2019 10:47:58 AM
From: Miljenko Zuanic
   of 508
 
So, it appears there is no 181 CRL and path to approval is intact.

MrM need update on 214 and path to first indication approval (IF at all).

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