It should be halted tomorrow during the panel, the length and timing of the panel and decision is anybody's guess but I would tend to believe mid to late afternoon tomorrow east coast time. If there would be a negative vote, then it would fall pretty hard as their would be assumptions that it would be a nail in the coffin...however, I would suggest you and others that have an investment in it read the comment from OPC11 (there are other good knowledgeable comments as well but he hits on a couple of key points from the briefing docs) on the following SA article http://seekingalpha.com/article/2117903-mannkinds-latest-critic-the-fda-has-joined-the-chorus-of-missing-data-concerns....you can read the article but the comment(s) that I refer to carries a lot more credibility and weight...the author of the article admits to going off Tarot card readings lol.....as for the meeting, my oldest son is suppose to attend so if anything of substance is worth noting in his interpretation I will post it tomorrow. As you would say....Best ;-)
It should be halted tomorrow during the panel, the length and timing of the panel and decision is anybody's guess but I would tend to believe mid to late afternoon tomorrow east coast time. If there would be a negative vote, then it would fall pretty hard as their would be assumptions that it would be a nail in the coffin...however, I would suggest you and others that have an investment in it read the comment from OPC11 (there are other good knowledgeable comments as well but he hits on a couple of key points from the briefing docs) on the following SA article http://seekingalpha.com/article/2117903-mannkinds-latest-critic-the-fda-has-joined-the-chorus-of-missing-data-concerns....you can read the article but the comment(s) that I refer to carries a lot more credibility and weight...the author of the article admits to going off Tarot card readings lol.....as for the meeting, my oldest son is suppose to attend so if anything of substance is worth noting in his interpretation I will post it tomorrow. As you would say....Best ;-)
Reb,
Again thanks for all the posts. Is there a specific blog you will be following tomorrow or just gathering info from your son? Either way look forward to tomorrow.
Reb,
Again thanks for all the posts. Is there a specific blog you will be following tomorrow or just gathering info from your son? Either way look forward to tomorrow.
This person (Matese) as they are known by on the Yahoo MB will be doing a live blog, has done them before as well:
Believe you just have to hit the connect button from what I understand. Also the two links that JMU supplied, the one from thestreet.com I am definitely not listening to as that is Adam Feuerstein's and I have no respect for nor attribute much credibility to. The other link is directly from the FDA for $200 as stated. I may be doing that one from my office with a few others but for those that don't want to incur the cost, the link from Matese should suffice. GL to all of us longs ;-)
Believe you just have to hit the connect button from what I understand. Also the two links that JMU supplied, the one from thestreet.com I am definitely not listening to as that is Adam Feuerstein's and I have no respect for nor attribute much credibility to. The other link is directly from the FDA for $200 as stated. I may be doing that one from my office with a few others but for those that don't want to incur the cost, the link from Matese should suffice. GL to all of us longs ;-)
Actually what JMU posted is the outline of the day's program, here is the link to be able to purchase the viewing webcast for $200
This article came out today in a this diabetic publication, it is from the editor and she also states that her managing editor along with her will be presenting to the panel as well tomorrow:
Skeptical of "fireworks" but we'll see. 4/15 is the big one. Wonder if shorts can hold on that long. I'm was surprised by the overwhelming votes though. As mentioned before it seems there will be strict labeling on it. I'll wait to see what Reb has to say.
Believe it or not, I'm thrilled for the Diabetics the most....I was in tears watching the testimonials during the public session, it was the people that need it and are demanding it that overwhelmed the panel and the FDA reps they deserve all the credit IMO. I knew when the first person spoke having known him from the MNKD msg board and how he described himself on the board and how he described how great the product was when he was in the trial that he would get their attention. We're we go from here, that was the major first step and approval should follow from the FDA on 4/15 if not before....there will be labeling and post studies required most likely for people with COPD and other pulmonary issues. Having said that, the biggest coup for the company is getting the technology approved at the same time. The way they process the drug and create the powder form so it can get into the deep lung is where they have 1000 patents submitted with 550 approved already. So if you don't need the cash right now I would take only what you want and leave the rest to grow with the company or eventually it gets bought by Big Pharma. I will have to look at the options and open interest to get a read of pricing levels as well. Will do that this evening and post prior to the open tomorrow. Great day and thrilled for everyone that tailed. Have a great evening...I'm going out and will have a toast to all of you -CHEERS!
Believe it or not, I'm thrilled for the Diabetics the most....I was in tears watching the testimonials during the public session, it was the people that need it and are demanding it that overwhelmed the panel and the FDA reps they deserve all the credit IMO. I knew when the first person spoke having known him from the MNKD msg board and how he described himself on the board and how he described how great the product was when he was in the trial that he would get their attention. We're we go from here, that was the major first step and approval should follow from the FDA on 4/15 if not before....there will be labeling and post studies required most likely for people with COPD and other pulmonary issues. Having said that, the biggest coup for the company is getting the technology approved at the same time. The way they process the drug and create the powder form so it can get into the deep lung is where they have 1000 patents submitted with 550 approved already. So if you don't need the cash right now I would take only what you want and leave the rest to grow with the company or eventually it gets bought by Big Pharma. I will have to look at the options and open interest to get a read of pricing levels as well. Will do that this evening and post prior to the open tomorrow. Great day and thrilled for everyone that tailed. Have a great evening...I'm going out and will have a toast to all of you -CHEERS!
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!
Nice call so far Reb. I went for the home run with the options so I'm not in the money yet but I love the huge one day jump. Lets get past 4/15 and we should have this thing well over 13 by August!
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.
Comments
still very pricey weeklys with a lot of volume
trading SCTY this afternoon
It should be halted tomorrow during the panel, the length and timing of the panel and decision is anybody's guess but I would tend to believe mid to late afternoon tomorrow east coast time. If there would be a negative vote, then it would fall pretty hard as their would be assumptions that it would be a nail in the coffin...however, I would suggest you and others that have an investment in it read the comment from OPC11 (there are other good knowledgeable comments as well but he hits on a couple of key points from the briefing docs) on the following SA article http://seekingalpha.com/article/2117903-mannkinds-latest-critic-the-fda-has-joined-the-chorus-of-missing-data-concerns....you can read the article but the comment(s) that I refer to carries a lot more credibility and weight...the author of the article admits to going off Tarot card readings lol.....as for the meeting, my oldest son is suppose to attend so if anything of substance is worth noting in his interpretation I will post it tomorrow. As you would say....Best ;-)
Reb,
Again thanks for all the posts. Is there a specific blog you will be following tomorrow or just gathering info from your son? Either way look forward to tomorrow.
http://www.thestreet.com/story/12561947/1/mannkind-the-best-afrezza-fda-panel-preview-ever.html
Also says you can pay $200 and watch for yourself.
agenda here:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM390857.pdf
This person (Matese) as they are known by on the Yahoo MB will be doing a live blog, has done them before as well:
http://widget00.mibbit.com/?settings=e8ed2c13c030aefd52a98054b9d977e0&server=irc.Mibbit.Net&channel=%23MNKD
Believe you just have to hit the connect button from what I understand. Also the two links that JMU supplied, the one from thestreet.com I am definitely not listening to as that is Adam Feuerstein's and I have no respect for nor attribute much credibility to. The other link is directly from the FDA for $200 as stated. I may be doing that one from my office with a few others but for those that don't want to incur the cost, the link from Matese should suffice. GL to all of us longs ;-)
Actually what JMU posted is the outline of the day's program, here is the link to be able to purchase the viewing webcast for $200
http://www.fdalive.com/webcastselect.cfm?meetingkey=10489
http://www.diatribe.org/issues/62/from-the-editor?utm_source=diaTribe&utm_campaign=2db9bdf7f7-diaTribe_Issue_62&utm_medium=email&utm_term=0_75cdadd67f-2db9bdf7f7-410691921
Any comments at the half way point?
After hour trading to start at 5:30 est time.
Thanks Reb!!!!!
@JJThommy 1m
20 minutes for trade resumption on $MNKD. Should be a fireworks show to say the least
Gitty up!!!
Margin man will come knocking tomm on the Shorts door will probably push this above 10
Great Job Reb and to everyone who held strong.. Congrats!!
Biggest ribeye and a bottle of Cakebread
Class act again, REB
Hits 10+ Wed IMHO
The vote shocked me 13-1 and 14-0
This product is a world innovation
Don't sell to fast
BEST
Now, about this ONVO...kidding.
Take care!
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!