I expect by the end of the day after some huge volume and volatility that there will be a relatively modest gain....the premiums on the options should come in a fair amount now that this first binary event is out of the way....there is still 4/15 and even though there is a high probability of approval, it would not be unprecedented for the FDA to not approve it. I still believe the short side will not go away quietly on this one, and until MNKD can get a partner they will keep some pressure on it IMO. I will most likely sell my May call positions today and keep my stock until further notice. GL everyone!
I just want to add a couple of things for everyone to be aware of as I had a good long chat with my son last night. He attended the ADCOMM and stayed through the entire meeting. A year ago I asked him his thoughts about MNKD and their concept etc., he did reply fairly instantaneously that he would be concerned about possible lung cancer issues....I thought well he really hasn't seen the data and what the testimonials were regarding the trial participants, etc. and he didn't get into specifics at the time.
Yesterday, the key discussion (at the ADCOMM) centered around the two cases of non smokers that developed lung cancer....the term IGF was brought up quite a bit along with IGF receptor. He reminded me of when I had asked him a year ago and he mentioned the concern about the lung cancer potential which I did while remembering thinking that was a quick response but attributed it to his being in the oncology area and that it would be a natural automatic type of response. Well during the discussion portion of the voting, the one panelist that voted no to Type 1 (vote was 13-1) but yes to Type 2 explained why and it makes a lot of sense now having talked with my son. The Type 1's would be taking/needing higher doses and would also be most likely starting at younger ages....compared to the Type 2's who would generally take lesser doses and start later in life when they develop the disease as older adults. Therefore, he felt the risk of developing lung cancer was much higher in the Type 1's.
Let's talk about the "IGF" term as that was what he (the one no vote) was referring to quite a bit. It stands for Insulin Growth Factor....as Insulin is a growth hormone. Well when you continually place it into the lungs there is the thought that those receptors eventually cause cancer cells to develop. So it helps understand and make logic of the one dissenting vote. Obviously they have not had years of study on this with Afrezza, so thus his reasoning, etc.
The panel felt the benefits outweighed the risks (along with the overwhelming public cry out for alternative treatments to be explored and given an opportunity compared to what currently exists) so there you have why the outcome was what it was. In the end, as I stated above the technology was validated, and I still believe the FDA will ultimately give its approval. However, it remains to be seen how the labeling and post study requirements come back. For the Type 2 market (which is the biggest and fastest growing sector) it is a no brainer, for Type 1 it may still be another story. As stated, will sell my May calls, and remain long my shares. Meanwhile, my son continues to impress me and gain my utmost respect ;-)
Question- With all this news public now, In theory the market is now very aware of what the value is on MNKD so it wont go up much more? Novice question I'm sure. Very nice call Reb, you know your stuff.
You both have got so much money it would take years to count it all---- meanwhile, I really have burned all mine this winter trying to stay warm up here in Goldfield. The good news-- I still haven't burned my MNKD stock certificate-- all 3.2 shares worth.
Meanwhile, my son continues to impress me and gain my utmost respect ;-)
Big thanks to you and your son Reb. No doubt you did a fantastic job raising him and preparing him to make a difference in this world. Thank you for that. And as you mentioned, we should all be first and foremost excited about the development of this drug in hopes that it will make the lives of those with Diabetes of more quality.
Now to the business side of things...you would suggest hanging on to the stock for the time being? I don't need the money at this juncture and obviously if there is potential for it to continue to rise then the route is to be long correct? What is the potential $ ceiling if approved on or before April 15? If not approved by FDA, will the stock drop to nothing? Just trying to weigh my options. Thanks again for everything Reb.
Big thanks to you and your son Reb. No doubt you did a fantastic job raising him and preparing him to make a difference in this world. Thank you for that. And as you mentioned, we should all be first and foremost excited about the development of this drug in hopes that it will make the lives of those with Diabetes of more quality.
Now to the business side of things...you would suggest hanging on to the stock for the time being? I don't need the money at this juncture and obviously if there is potential for it to continue to rise then the route is to be long correct? What is the potential $ ceiling if approved on or before April 15? If not approved by FDA, will the stock drop to nothing? Just trying to weigh my options. Thanks again for everything Reb.
Thanks for the kind words Cools, as far as staying long and price projection with or without FDA, my thoughts are as follows: I am staying long my shares as I fully expect FDA approval. The approval most likely will come with some "added attachments" which I'm sure the shorts will try and make an issue of. BUT getting Afrezza approved to me was the big wall to knock down, that validated their technology which in the bigger picture (economically speaking) of the valuing the company is huge IMO. So price after approval should send this into low double digits again IMO....just an 8-10 billion market cap would put the price in the 15 area (counting for current outstanding and warrants outstanding) but the addition of a huge partner would set the stage for a massive short problem and no telling where that would put them as that can overshoot expectations. With the outside chance (approx 20% statistically speaking) that they do not approve the downside would be very ugly, but after seeing the response from the Diabetic and Endocrinology community, that is not and has not been a possibility on MY radar ;-) ....hope that helps you as well as the others as far as where I'm still at. GL
Just like when you feel/believe strongly you have the right side and the market brings you a better number, I added to my position today fwiw to those following. From a technical standpoint, the gap that occurred after monday's close left an "abandoned" candle on the chart and some may make the mistake of thinking the price will come back and fill it....to me it was more evident of what is called a "breakaway gap" which is more evident of a longer term move and coupled with the abandoned candle sets up for a nice reversal from the lows put in monday before the adcom. Nothing is always guaranteed but the almost 100 mill. shares traded (heaviest volume in quite some time) yesterday usually is also a confirming indication that a reversal breakout occurred. So just like someone that looks at a game and their models are screaming at them I had to take advantage and add today. GL all
Just like when you feel/believe strongly you have the right side and the market brings you a better number, I added to my position today fwiw to those following. From a technical standpoint, the gap that occurred after monday's close left an "abandoned" candle on the chart and some may make the mistake of thinking the price will come back and fill it....to me it was more evident of what is called a "breakaway gap" which is more evident of a longer term move and coupled with the abandoned candle sets up for a nice reversal from the lows put in monday before the adcom. Nothing is always guaranteed but the almost 100 mill. shares traded (heaviest volume in quite some time) yesterday usually is also a confirming indication that a reversal breakout occurred. So just like someone that looks at a game and their models are screaming at them I had to take advantage and add today. GL all
I'm trying to assign a % that the FDA actually makes their decision on 4/15. I have read it's possible they delay it 90 days or even just a couple weeks since the AdCom panel was so recent. Your 2 cents on that?
The April call at $10 strike for 15 cents looks awfully good but only if I can be sure the FDA makes a decision. If so and approved, it's at least $12 overnight much like the AdCom decision.
I'm trying to assign a % that the FDA actually makes their decision on 4/15. I have read it's possible they delay it 90 days or even just a couple weeks since the AdCom panel was so recent. Your 2 cents on that?
The April call at $10 strike for 15 cents looks awfully good but only if I can be sure the FDA makes a decision. If so and approved, it's at least $12 overnight much like the AdCom decision.
There is always that possibility with the FDA, specifically with their history regarding their past with this situation nothing would surprise me. If I were going the option route I would most likely go with some type of calender call spread something like buying the Aug calls and selling a higher strike with a closer expiration against it if you want to reduce your cost on the Aug calls. Remember the accusation that they were supposedly hiding something from the trial results was brought up by the naysayers. In reality what they said is they wouldn't be able to present at the ADA meeting in June if certain things were published prior...my take is those are most likely some very positive points so having the Aug. calls will give you much more time for upside whether it is positive presentation at the annual ADA conference or perhaps some type of partnership agreement post approval but after April along with removing the risk of any delay announcement.
There is always that possibility with the FDA, specifically with their history regarding their past with this situation nothing would surprise me. If I were going the option route I would most likely go with some type of calender call spread something like buying the Aug calls and selling a higher strike with a closer expiration against it if you want to reduce your cost on the Aug calls. Remember the accusation that they were supposedly hiding something from the trial results was brought up by the naysayers. In reality what they said is they wouldn't be able to present at the ADA meeting in June if certain things were published prior...my take is those are most likely some very positive points so having the Aug. calls will give you much more time for upside whether it is positive presentation at the annual ADA conference or perhaps some type of partnership agreement post approval but after April along with removing the risk of any delay announcement.
I already have August calls with a $13 dollar strike. This April $10 call for 15 cents is just so damn tempting though. That's dirt cheap. I think approval is a foregone conclusion with this combined 27-1 vote. It's just risky about the timing because if they do push back my options will 100% expire worthless. But 15k to make anywhere from 200-500k is incredibly good odds if everything goes as scheduled. I don't think it's unrealistic for the stock to be at 12 overnight pending the decision and then I have 3 full trading days for CNBC to hype it, the short squeeze, etc. I just don't think I can pass that up. I don't bet baseball anyways so fuck it, put my money in something.
Edit: I did read that the FDA has every opportunity to make the AdCom in Feb or March and chose not to. That perhaps they aren't too worried they;ll need a lot of time to make a final decision. But maybe at this point I'm just reading what I want to hear.
IMO you are much better off straddling buying $7 calls and puts, you betting on volatility (with technically unlimited upside), no approval or delay your put should be ITM, approved and hopefully your calls are worth a 500k. good luck
05:51 EDT MNKD "MannKind announces FDA extension of PDUFA date for Afrezza
MannKind announced that the FDA has extended the Prescription Drug User Fee Act, or PDUFA, date for Afrezza by three months to July 15 in order to provide time for a full review of information submitted by MannKind in response to the FDA's requests."
Can someone tell me what PDUFA is? Is this the April 15th meeting?
05:51 EDT MNKD "MannKind announces FDA extension of PDUFA date for Afrezza
MannKind announced that the FDA has extended the Prescription Drug User Fee Act, or PDUFA, date for Afrezza by three months to July 15 in order to provide time for a full review of information submitted by MannKind in response to the FDA's requests."
Can someone tell me what PDUFA is? Is this the April 15th meeting?
Yep extended now to 7/15....welcome to the FDA folks
The question is when early July rolls around will I be able to find similarly priced call options. I'm quickly realizing the FDA can do whatever they want but ya gotta figure 7/15 is gonna be the final decision day. Oh well, I can wait 90 days.
So common sense says if the FDA wanted to reject they would have done so by 4/15, in other words why would you delay a rejection. So this looks more in line with taking time to get the labeling put together. Price action this morning looks actually supportive with the 6 handle holding the news well. The large open short interest acts like a floor now as they try to figure exit strategies. I expect the pps to start to have an approval priced in by the 7/15 date if not sooner, with the recent events both the ADCOM and this open the door for more posturing and negotiations with potential partners (hopefully some type of bidding war develops now that they see the potential with this). I continue to remain long and will continue adding when the opportunity presents itself.
Yep extended now to 7/15....welcome to the FDA folks
What's your opinion on this news Reb? Good, bad, indifferent?
Yes, the FDA can be finicky. My wife was telling a story last night about a drug that her PI developed that was purchased by Pfizer and not approved by FDA because they were "mad" at Pfizer for not properly executing the clinical trial. The drug is approved in Europe and has helped many many people.
Lets see how far this bad news will take it down, I'm far from an expert but the present price of $6.05 sounds like an add to me but I'm thinking a little more panic selling may get this to 5.00 over the next week or two which IMO wouldn't be a bad think at this point. But as I said far from a expert but have to admit enjoying the ride.
Lets see how far this bad news will take it down, I'm far from an expert but the present price of $6.05 sounds like an add to me but I'm thinking a little more panic selling may get this to 5.00 over the next week or two which IMO wouldn't be a bad think at this point. But as I said far from a expert but have to admit enjoying the ride.
Price behavior is an indication of where the money is going and like you said the face of the news would have made one think it would be lower so as you say in your aged wisdom (lol) this looks more like a sale and discount for what portends down the road old wise one ;-)
The following link is from the first speaker at the ADCOM, his name is Sam and he goes by afrezzauser on the Yahoo MB. The link shows the force that the panel and reviewers were reckoned with the public speaker portion of the meeting. The letters that he wrote are also on there as well as a letter/petition to the FDA, ...enjoy!!
The following link is from the first speaker at the ADCOM, his name is Sam and he goes by afrezzauser on the Yahoo MB. The link shows the force that the panel and reviewers were reckoned with the public speaker portion of the meeting. The letters that he wrote are also on there as well as a letter/petition to the FDA, ...enjoy!!
Reb at what price do you see as an adding price as stated above? Thanks for the awesome advice and responses, I have learned a ton the last 6 mos here with your wisdom.
Reb at what price do you see as an adding price as stated above? Thanks for the awesome advice and responses, I have learned a ton the last 6 mos here with your wisdom.
Thanks GG
The low 6's today, it may go lower but I'm in the camp that there is risk being out of it because now at any time an announcement can come that would put it at new 52 week highs...I am starting to think like George that Novo Nordisk will make a play for them, it makes sense as it will eliminate their competition (Novolog) while giving them the rights to the whole enchilada with the technology as well. JMHO so take it fwiw. GL
Comments
I just want to add a couple of things for everyone to be aware of as I had a good long chat with my son last night. He attended the ADCOMM and stayed through the entire meeting. A year ago I asked him his thoughts about MNKD and their concept etc., he did reply fairly instantaneously that he would be concerned about possible lung cancer issues....I thought well he really hasn't seen the data and what the testimonials were regarding the trial participants, etc. and he didn't get into specifics at the time.
Yesterday, the key discussion (at the ADCOMM) centered around the two cases of non smokers that developed lung cancer....the term IGF was brought up quite a bit along with IGF receptor. He reminded me of when I had asked him a year ago and he mentioned the concern about the lung cancer potential which I did while remembering thinking that was a quick response but attributed it to his being in the oncology area and that it would be a natural automatic type of response. Well during the discussion portion of the voting, the one panelist that voted no to Type 1 (vote was 13-1) but yes to Type 2 explained why and it makes a lot of sense now having talked with my son. The Type 1's would be taking/needing higher doses and would also be most likely starting at younger ages....compared to the Type 2's who would generally take lesser doses and start later in life when they develop the disease as older adults. Therefore, he felt the risk of developing lung cancer was much higher in the Type 1's.
Let's talk about the "IGF" term as that was what he (the one no vote) was referring to quite a bit. It stands for Insulin Growth Factor....as Insulin is a growth hormone. Well when you continually place it into the lungs there is the thought that those receptors eventually cause cancer cells to develop. So it helps understand and make logic of the one dissenting vote. Obviously they have not had years of study on this with Afrezza, so thus his reasoning, etc.
The panel felt the benefits outweighed the risks (along with the overwhelming public cry out for alternative treatments to be explored and given an opportunity compared to what currently exists) so there you have why the outcome was what it was. In the end, as I stated above the technology was validated, and I still believe the FDA will ultimately give its approval. However, it remains to be seen how the labeling and post study requirements come back. For the Type 2 market (which is the biggest and fastest growing sector) it is a no brainer, for Type 1 it may still be another story. As stated, will sell my May calls, and remain long my shares. Meanwhile, my son continues to impress me and gain my utmost respect ;-)
I feel shorts are still trying to cover
I am in it for the long haul
Just bought 5000 more shares at 7.06
This product is truly innovative
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If I had your money Okie I'd burn mine
You both have got so much money it would take years to count it all---- meanwhile, I really have burned all mine this winter trying to stay warm up here in Goldfield. The good news-- I still haven't burned my MNKD stock certificate-- all 3.2 shares worth.
Quoth the Raven
Long/short equity, contrarian, special situations, wild cards
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MannKind's FDA Win Is A Short Seller Massacre
Big thanks to you and your son Reb. No doubt you did a fantastic job raising him and preparing him to make a difference in this world. Thank you for that. And as you mentioned, we should all be first and foremost excited about the development of this drug in hopes that it will make the lives of those with Diabetes of more quality.
Now to the business side of things...you would suggest hanging on to the stock for the time being? I don't need the money at this juncture and obviously if there is potential for it to continue to rise then the route is to be long correct? What is the potential $ ceiling if approved on or before April 15? If not approved by FDA, will the stock drop to nothing? Just trying to weigh my options. Thanks again for everything Reb.
Thanks for the kind words Cools, as far as staying long and price projection with or without FDA, my thoughts are as follows: I am staying long my shares as I fully expect FDA approval. The approval most likely will come with some "added attachments" which I'm sure the shorts will try and make an issue of. BUT getting Afrezza approved to me was the big wall to knock down, that validated their technology which in the bigger picture (economically speaking) of the valuing the company is huge IMO. So price after approval should send this into low double digits again IMO....just an 8-10 billion market cap would put the price in the 15 area (counting for current outstanding and warrants outstanding) but the addition of a huge partner would set the stage for a massive short problem and no telling where that would put them as that can overshoot expectations. With the outside chance (approx 20% statistically speaking) that they do not approve the downside would be very ugly, but after seeing the response from the Diabetic and Endocrinology community, that is not and has not been a possibility on MY radar ;-) ....hope that helps you as well as the others as far as where I'm still at. GL
I'm trying to assign a % that the FDA actually makes their decision on 4/15. I have read it's possible they delay it 90 days or even just a couple weeks since the AdCom panel was so recent. Your 2 cents on that?
The April call at $10 strike for 15 cents looks awfully good but only if I can be sure the FDA makes a decision. If so and approved, it's at least $12 overnight much like the AdCom decision.
There is always that possibility with the FDA, specifically with their history regarding their past with this situation nothing would surprise me. If I were going the option route I would most likely go with some type of calender call spread something like buying the Aug calls and selling a higher strike with a closer expiration against it if you want to reduce your cost on the Aug calls. Remember the accusation that they were supposedly hiding something from the trial results was brought up by the naysayers. In reality what they said is they wouldn't be able to present at the ADA meeting in June if certain things were published prior...my take is those are most likely some very positive points so having the Aug. calls will give you much more time for upside whether it is positive presentation at the annual ADA conference or perhaps some type of partnership agreement post approval but after April along with removing the risk of any delay announcement.
I already have August calls with a $13 dollar strike. This April $10 call for 15 cents is just so damn tempting though. That's dirt cheap. I think approval is a foregone conclusion with this combined 27-1 vote. It's just risky about the timing because if they do push back my options will 100% expire worthless. But 15k to make anywhere from 200-500k is incredibly good odds if everything goes as scheduled. I don't think it's unrealistic for the stock to be at 12 overnight pending the decision and then I have 3 full trading days for CNBC to hype it, the short squeeze, etc. I just don't think I can pass that up. I don't bet baseball anyways so fuck it, put my money in something.
Edit: I did read that the FDA has every opportunity to make the AdCom in Feb or March and chose not to. That perhaps they aren't too worried they;ll need a lot of time to make a final decision. But maybe at this point I'm just reading what I want to hear.
MannKind announced that the FDA has extended the Prescription Drug User Fee Act, or PDUFA, date for Afrezza by three months to July 15 in order to provide time for a full review of information submitted by MannKind in response to the FDA's requests."
Can someone tell me what PDUFA is? Is this the April 15th meeting?
Yep extended now to 7/15....welcome to the FDA folks
You can see now why I responded Aug. options to your question, those .15 calls you were talking about...you know the adage: if it looks too easy....
What's your opinion on this news Reb? Good, bad, indifferent?
Yes, the FDA can be finicky. My wife was telling a story last night about a drug that her PI developed that was purchased by Pfizer and not approved by FDA because they were "mad" at Pfizer for not properly executing the clinical trial. The drug is approved in Europe and has helped many many people.
Price behavior is an indication of where the money is going and like you said the face of the news would have made one think it would be lower so as you say in your aged wisdom (lol) this looks more like a sale and discount for what portends down the road old wise one ;-)
http://samfinta.blogspot.com/
Adding an excellent article by George Rho which really covers the spectrum IMO, link below
http://seekingalpha.com/article/2129553-the-27minus-1-adcom-votes-have-so-many-positive-implications-for-mannkind
Thanks GG
The low 6's today, it may go lower but I'm in the camp that there is risk being out of it because now at any time an announcement can come that would put it at new 52 week highs...I am starting to think like George that Novo Nordisk will make a play for them, it makes sense as it will eliminate their competition (Novolog) while giving them the rights to the whole enchilada with the technology as well. JMHO so take it fwiw. GL
http://www.thestreet.com/story/12632495/1/will-this-coverage-initiation-help-mannkind-mnkd-stock-today.html?puc=yahoo&cm_ven=YAHOO
http://www.thestreet.com/story/12653353/1/mannkind-rival-also-developing-inhaled-insulin-device-files-75m-ipo.html?puc=yahoo&cm_ven=YAHOO
Added to MNKD position
Dollar cost averaging
20,000 shares at 6.01 now
Love this story
Hope to see low teens by 8-01-14
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