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MNKD short interest = 21,476,500 WOW!
MNKD - let's see if raid = FDA approval once again.
MNKD - yeah, heard there was a cub raid over there.
In an almost $2B market with a significant reduction in side effects such as dizziness and somnolence, as well as a more convenient once daily (QD) dosing profile versus the 3-4x daily for generic gabapentin.....if it's not ABT, another biggie will jump on board. DEPO alredy has 2 drugs approved and selling, so it's not their 1st go around here. They also have other drugs in the pipeline, including a significant one in Phase III. This is not a one hit wonder company.
Yes, that is a rock we should have unturned. I'm not concerned at this point, with or without ABT. They are still on the hook financially. Ideally, they would play nice, but that's business. My focus again is approval, which I feel is quite likely, as does DEPO and ABT, apparently. Also, with the FDA giving Orphan Drug Status, it's pretty clear they are on board too.
DEPO - so here are the out clauses: I SEE NONE THAT APPLY.
“Termination Event” means any
(a) withdrawal of the Product in the Field from the market in the Territory,
(b) material medical or scientific concerns as to toxicity, safety and/or efficacy of Product in the Field,
(c) written request of any Governmental Authority or the applicable institutional review board or data safety monitoring board to stop clinical trials of the Product in the Field,
(d) failure of the Product to meet all primary endpoints in clinical trials conducted prior to Regulatory Approval of Product in the Field,
(e) a Patent Right controlled by a Third Party is identified that is not included in the Depomed Patents and that is not otherwise licensed to Solvay, which Patent Right (i) claims inventions reasonably necessary for the manufacture, use, sale, offer for sale or import of the Product in the Field in the Territory and (ii) is not available for licensing or otherwise transferable to Solvay on terms reasonably acceptable to Solvay, or
(f) any of the following events: (i) a determination that the Product is not approvable by FDA, as evidenced by a written communication from FDA to Solvay, its Affiliate or sublicensee;(ii); or (iii) managed care providers, comprising at least a majority of the managed care environment in the United States, blocking, materially restricting (including, without limitation, imposition of step edits or prior authorizations) or declining coverage and/or reimbursement for the Product.
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DEPO - and the more I think about it, the more I'm ok with the worst case you outlined. My initial reaction was obviously not a good one, but the more I look into this, the better I feel. Upon approval, I think this will all come together nicely and think the same price targets are in play.
DEPO - see contract (except for some confidential parts) here:
http://www.sec.gov/Archives/edgar/data/1005201/000104746909002319/a2191276zex-10_45.htm
I don't see ABT getting out of this one without paying a substantial amount of money. You'll also see in here the details of the launching of the drug. How they can even say they don't have to launch is pretty funny.
Another thing that came to mind was that Solvay already applied for trademarks for the new drug name (gotta find that link). Basically, everything is lined up and ready to rock upon approval. I still think ABT just wants to renegotiate the deal. For example, DEPO will get $35M on approval, but another $25M with favorable labeling. This might be a point that ABT wants to hash out. In addition, possibly lowering the % for royalties.
You will also find the dispute process in here.
DEPO - they brought this down on air a/h. Not many shares traded to get it to $5.00. Hoping it heads back up on air too.
DEPO - Well, on a positive note, this should eliminate the potential of a bear (or cub) raid. I'm sure they would be happy to cover here.
The fact that ABT did all that work in Nov, 2010 to get orphan drug status and now (only ~8 weeks later), they are pulling this, shows me that they are trying to strongarm DEPO into a better deal. I think there's too much revenue potential here to let it go and ABT knows that this puts DEPO in a tough position, even if it's a temporary tough spot.
If that's the case, their approach is very unprofessional, given the fact that they have been working with DEPO on this for quite some time.
We're -26% right now, which is really nuts and not justified. Yes, the ABT issue and timing sucks, but only a temporary issue. Nothing has changed with our DD leading into the PDUFA. There is clearly a huge market here for the drug, hence the Orphan status.
Yes, I agree with you completely.
DEPO - added some shares at $5.27.
DEPO - this will iron itself out. Approval still likely.
DEPO advised that they are not in a position to launch on their own. If ABT continues to fight the contract, it could take 3-8 week for arbitration.
There has to be more to this with regards to ABT.
Why the heck would ABT want to pull out? I'm so lost here.
I have a feeling we end up there tomorrow on a gap down. This is a nightmare.
DEPO - I hope we get an approval tonight and we destroy these crooks.
Here comes the last ditch effort for today!! The support and buying today threw them for a bit of a loop I think.
DEPO - added again at $6.59.
Agreed. I've watched L2 for months and that looked like a raid to me.
DEPO - we all know what the outcome has been after these bear raids...they start covering, price goes back to where it started, approval and major price appreciation. Looking for the same on DEPO!!
I was actually thinking the same. I think this should be a pretty straight forward approval, so it could come early. We'll see.
OT: "cub raid" LOL!!
Yes, I'll take that too!
Approval a/h tonight would be so sweet!! Here's hoping!!
DEPO - added $6.56.
DEPO - just added a few more at $6.90
DEPO - just added at 6.95 and 6.96.
DEPO - totally agree. This is where you rely on the DD that has been performed and know what you own.
DEPO - same here. I'm ready with dry powder this time, not like AVNR.
DEPO - gotta agree with you there. Shorting, profit taking, fear of bear raid all contributing to this, I would assume.
DEPO ($6.93) - pulled right back to the 9 day moving avg ($6.91), like it's been doing for months during consolidation. Bounced right off of it.
LCI - the original date was 12/26. I don't recall seeing a formal delay. Any idea what happened there?
The next 5 FDA decisions:
LCI Past Due
CLDA Jan 22
MNKD Probably the week of Jan 24
DEPO Jan 30
OREX Jan 31
I don't think OREX will be approved this round, even though there was a positive vote from the panel. I listened to the meeting and the FDA seemed pretty uncertain to me. Agree with buying these for the run-up, but to hold through the decision date would be like going to Vegas.
Great, didn't see that. Thanks.