This Marriott has a Potomac Ballroom. But nobody on the staff knows if it is reserved for the AdCom. However, this Marriott has a special rate for the Adcom so it must be it. Within a week of the meeting, the Marriott staff should be able confirm the AdCom at their hotel.
It is a big deal. MNKD should be moving up in advance of AdCom and PDUFA. MNKD's price spiked to close to $9.00 when the NDA was filed. One can only presume that somebody knows something that you do not know. Then you get into a a Yogi Berra type logic anomaly : Can the unknowable hurt you if you don't know it?
I will be attending the AdCom and would be interested in your real time blog. Also, I will tune in to Adam Fuerstein's (sp?) blog on the events.
It should be interesting.
Your post begs two questions: First, why would a short pay 50% to acquire shares to short given the circumstances of AdCom and PDUFA? Secondly, why are there so shares to short compelling Schwab to dip down into the retail level?
Candy Crush, whose eponymous mobile game can mindlessly entertain you, is going to sell IPO shares valuing the company at $6.7 bln. In this light, can MNKD be valued at $10 bln? Solving a critical care issue for diabetics has got to be more important than wiping out jellybeans. The market has the final say, but I envision a high valuation for MNKD. In roughly a fortnight, we will know.
Shorting the $3 April 19th puts is a good play. More than likely, the stock price will spike up after AdCom so you will be able to buy puts to close before April 19th for good profit.
It is not possible for an FDA delay and MNKD to get the extra funds from Deerfield. Deerfield's loan is available only on approval.
Thanks to George Rho, I have a better understanding on the recent Deerfield convertible extension. I was troubled that the deal had no 'consideration' for MNKD. Thanks to George, the consideration is an extension of up to $90 mln additional credit line available to MNKD post approval.
The AMT is another small time instrument that functions like a secondary.
This leads me to infer from these actions that MNKD is positioning for a partnership post approval. If it were a buy-out, MNKD would have no further need for cash. If it were nothing, i.e. MNKD to go alone to market, then MNKD will need much larger quantities of cash. The amount raised via AMT + Deerfield conversion is Goldilocks size - enough to partner with.
MNKD's AdCom will be held in the College Park Marriott in Hyattsville MD. The Marriott has a special AdCom rate of $224/nite. Marriott's central reservation has this price with no cancellation possible - like a Priceline deal. This is wrong as cancellation is possible by 6 pm the date of arrival. This is important to us since the AdCom date can move. I advise making the reservation directly with the property.
Medallion, whose products are infusion based has nothing to do with Technosphere, an inhaleable product. Al has been in the infusion business for years and this is just another variant. Another company located close to Valencia is Palyon who also makes an infusion product. They have struggled which does not bode well for Medallion.
Using DNDN and ARNA Boards as templates, the MNKD Board will still be active post approval. Naturally we won't have the idiot shorts who belch black smoke. Investors love to talk about winners.
Covered calls are simple animals. If you sell a call, the money is in your account the next day. If the stock price rises above the strike price, it can be called away before expiration. This only happens in rare circumstances most of which involve a dividend. If the stock price rises well above the strike price, you can close out the position: buy call to close, sell stock. The money then can be invested in another stock and another sell call to open.
The premium is yours; win lose or draw on the strike price.
Having said all this, a covered call is not appropriate for MNKD. Yes, you can make huge premiums, but the real money is on the FDA approval. If the FDA does not approve, MNKD drops like a rock and the cc premium earned is insignificant to the risk you have taken.
The recent POSASR and AMT filings amount to dilution if they are exercised before AdCom or PDUFA. If Deerfield want to roll the dices with MNKD, they will exercise within the next 3 weeks. AMT is different as the option to sell belongs to MNKD. If they don't need the cash, they should wait until after PDUFA when presumably the share price is up.
Dilution it is but not a whole lot.
On or before March 28th, the FDA will issue the background material for the ADCom meeting. If the FDA's material cast a positive spin on the situation, I can see the price spiking to above $7.
I am short the March 28th $5 puts incurring the opposite risk of the call writer. But I am willing to live with this.
You are way too erudite for this Board.
In the fussy way the FDA works, an non-inferiority clinical trial ends up with a product having the same label as the incumbent. To make a claim that Afrezza provides superior glucose control requires another clinical trial. The FDA and AdCom members are not dummies; they know a better product when they see it. It may not fit conventional standards; Disruptive technology rarely conforms. If for nothing else, Afrezza will be approved so that Mannkind can develop its full therapeutic potential.
A contradiction that most shorts haven't figured out is this: How can a BP testify at AdCom that Afrezza is bad when at the same time they are negotiating or have negotiated with MNKD to partner with them. Only the most respected clinician or researcher in insulin therapy will have any standing at AdCom. These people cannot be bought off by BP as they will lose their standing with their peers. Within this circle, science rules the roost, not money.
I have been to several medical device AdComs. Attendance was healthy, not SRO at all. However, Afrezza has a much higher profile than any medical device I was involved in. I expect SRO.
The sponsor, Mannkind will be on the hot seat. Almost like defending a PhD thesis. Users will be foresquare behind Afrezza. I just don't know of any group that would be against it.
This document chronicles the hiring to two stock sales agents to sell treasury MNKD stock. Up to 25 mln shares can be sold so the dilution is not great. MNKD will certainly wait until after PDUFA to sell stock if needed. It seems to me that this move is put into place if the PDUFA goes the wrong way. But by then, the stock is $2 shares which will bring in $50 mln.
At one of the investment forums recently, Pfeiffer said clearly that Deerfield saw the same clinical data that was disclosed to the public. This means only the rolled-up high level summaries.
I agree with your assessment of Reg FD if Deerfield saw detailed clinical data.
In rooting around the web, I discovered that Deerfield does not own MNKD stock. Did they sell it?
Your posts reads much like the ones I get from Nigeria. They go like this: ...a man with your last name recently died leaving a large sum of money....
If you were running a BP company in the diabetes market would you 1) Try and partner with MNKD or 2) use devious methods to undermine the FDA approval process? I think 1) is more likely and the easier route to take.
But the current antics of Vladimir Putin teaches us all that human nature can be treacherous. If at the AdCom, I see people appeal to the Board to limit the label for non-sensiscal reasons, then you and SA are correct: The fix is in. I just don't see that happening. It would have to come from a CMO of a BP company. These people have a scientific bent and would hate to face their peers having just non-scientifically attacked Afrezza at the AdCom.
Life is full of inconsistencies. I see the huge short position as such and it worries me. Otherwise, I see success for MNKD.