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  • Maybe I'm Wrong - Justifying $2,000+ Gold [View article]
    Likely just trying to generate some views as he knows this is a highly debated topic that will generate many clicks for himself. His disclosure and opinions on miners are completely opposite of his opinion. Why would you be long at 1240 and have a view it is going to 800? Why would you recommend miners if gold is going to be crushed by a third?
    Jun 2, 2014. 09:10 PM | 3 Likes Like |Link to Comment
  • Lucas Energy Announces Eagle Ford Deal That Has Potential To Turn The Company Around [View article]
    "The only way for LEI to raise cash is through deals like this or an equity raise. I can't help but think that the NYSE (an equity exchange) is going to require a significant equity raise?"

    Offering is 11% of current shares out at over 10% below current market price with warrants that are fairly far out of the money.

    http://bit.ly/1hUE2Uq
    Apr 16, 2014. 08:19 AM | Likes Like |Link to Comment
  • History Shows MannKind Has A Near Certain Chance Of Approval [View article]
    Realistic thoughts on the delay announced today? A delay can't be good for approval. If this was slamdunk approval, why not just approve on the 15th? Why another three months? I don't really buy that it was expected to be delayed given the market reaction today. Down 10% on heavy volume.
    Apr 7, 2014. 10:05 AM | Likes Like |Link to Comment
  • Lucas Energy Announces Eagle Ford Deal That Has Potential To Turn The Company Around [View article]
    The PR out yesterday has made me sell out my position. Obviously it is good that the NYSE accepted LEI's plan, however what is in that plan is relatively unknown.

    "The determination is contingent upon the completion of the recently-announced participating agreement with an independent operator in the Eagle Ford shale and achieving other milestones outlined in the plan."

    Some have pointed out the fact that LEI must get the Eagleford deal done by April 14th to satisfy the NYSE. They fear that the operator may take advantage of LEI due to the deadline.This is true and a valid concern. However, this is not my main concern. "Other milestones" are my main concern. I'm pretty sure I was wrong about the EF deal satisfying the NYSE due to this other milestone talk. We simply do not know what those milestones are as the plan submitted to the NYSE is, to my knowledge, not public. The only way for LEI to raise cash is through deals like this or an equity raise. I can't help but think that the NYSE (an equity exchange) is going to require a significant equity raise? I have no clue what their requirements for the financial condition to be? Anyone have any more insight on this process?
    Apr 3, 2014. 06:44 PM | Likes Like |Link to Comment
  • History Shows MannKind Has A Near Certain Chance Of Approval [View article]
    Vince,

    He's on your side buddy. He's just showing a comparison between the results of ADCOM votes and the resulting FDA votes since the ADCOM is not binding on the FDA.
    Apr 2, 2014. 10:03 AM | 6 Likes Like |Link to Comment
  • History Shows MannKind Has A Near Certain Chance Of Approval [View article]
    Good data! Here's to helping you get your $29 back! Based on this data, FDA approval should be pretty much baked in the price? Or do you think it can run higher? Surely seems like it would be priced in here given the numbers you have showed and the convincing panel vote.

    What are your thoughts on lack of partnership so far? What do you think MNKD's plan is? Lots of longs seem to think a partner is just waiting for FDA approval. Why did they modify the DF deal and arrange the ATM deal if a partner is waiting for FDA approval?

    Thanks and congrats again.
    Apr 2, 2014. 09:59 AM | 6 Likes Like |Link to Comment
  • MannKind - A Trail Of Failure Leading To Success [View article]
    I've got comments on one of the recent articles. Hard to follow all of the articles since there are so many and most have a zillion comments. Still lingering concerns including FDA & partnership. Hard for FDA to go against MNKD now, but partnership a big concern I think. For now it is a good day for longs though. Congrats.
    Apr 2, 2014. 09:50 AM | 1 Like Like |Link to Comment
  • MannKind - A Trail Of Failure Leading To Success [View article]
    Tri Duong seems to agree with me regarding status of management and the things they have pulled. Just because they got a favorable vote at ADCOM doesn't mean the things said above about management haven't happened. Afrezza would have been approved probably 2 or 3 years ago if they had just listened to the FDA. That's pretty big. How much dilution, debt, etc has happened since then?

    Regarding ADCOM, I thought it would be more negative, leaning towards the FDA view of things. Ultimately FDA has the final say anyways so who knows. Hard for them to go against that sort of ADCOM vote, but there is nothing saying they have to. Not likely, but things could still change.

    I could care less either way what happens as I have no position. Bought in originally around 4 and sold out at 6. I can't ever complain if I make money. Missed some of the pop, but it sure was a roller coaster getting there. I think the market cap is priced for perfection. It currently sits at $3.2B+ with no sales and no partner. Big shoes to fill. If a partner is not announced after an FDA approval, stock will definitely drift down IMO. I'm not convinced they have a partner. What's the reasoning behind the ATM and the DF amendment? BTW, not everyone who has an opinion on a stock has a position...
    Apr 1, 2014. 08:15 PM | 3 Likes Like |Link to Comment
  • What The FDA Document Says About Afrezza: Implications For FDA Approval [View article]
    Same to you sir. Congrats on the ADCOM results. I haven't commented too much on here. I've been mainly watching Adam's blog and Twitter. I think I get like 4 or 5 notifications on MNKD articles and there are way too many comments on each article to scroll through. I certainly thought the panel would be more critical of the drug and side more with the FDA. I thought the sole no vote on T1 made sense. The inhaled vs injected/oral risk reward isn't there for me. We'll see what the FDA has to say in a couple weeks. They seemed to be pretty fixated in their position. Magnitude of ADCOM vote will be hard for FDA to ignore though. A 7-7 vote sure would have been fun for trading tomorrow!

    Anyways, any idea of a realistic price target for tomorrow? I have no idea. Obviously there is going to be a flurry of activity. Certainly some shorts will be getting destroyed, other shorts will double down on FDA or commerciality issues, longs will be buying, DF will likely be shorting any big pop, MNKD might be hitting the ATM, and financing/partnership is still unsolved. Lots of unknowns.

    I would think that if MNKD had any sort of partnership in the bag, now would be the time to announce it. Would be an absolute knockout punch for the shorts given that a lot of folks thought ADCOM was going to be bad.

    What do you think about the partnership/financing/... side of things? Obviously this is a critical item because they can't do anything on their current cash stash and launching a new drug takes a ton of money. I'm so skeptical of management talks of partnerships in the works. They have been saying that for a long time now. If they don't announce a partner after an FDA approval, I can see the stock heading down.

    I'm not sure why they would have done the ATM agreement & the additional DF money if they had a partner in the works? Doesn't really make sense to me. Does it to you?

    I almost bought some calls for a sheer gamble due to the stock getting beat down so much. Glad I didn't do anything on the short side. Again, congrats and good luck in a couple weeks. Look forward to hearing your responses.
    Apr 1, 2014. 05:26 PM | Likes Like |Link to Comment
  • MannKind - A Trail Of Failure Leading To Success [View article]
    You only think there is a small chance of a CRL for another study on dosing? The second CRL was related to dosing changes and the inhaler change. Certainly changing dosing (amount of powder in the lungs) can change the safety profile, no? Seems like that would require another trial.

    "However, FDA considers the corresponding pharmacodynamics (PD) effect to be equally or more important in evaluating the adequacy of the proposed dosing regimen because it is the PD effect that ultimately drives efficacy (i.e., HbA1c reduction). Considering this, we find that the clinical pharmacology data in this submission does not adequately support the new
    proposed dosing regimen and the respective dosing conversion factors in the dosage chart (discussed in section 2)."

    "Table 2 clearly indicates that the recommended dosing conversion proposed to go from subcutaneous insulin to Gen-2 delivered Afrezza insulin (refer to data in 5th column) is not consistent with the data from PK/PD study (refer to data in 4th column). Further, these data also do not adequately support the dosing regimen tested in Phase 3 trials MKC-TI-171 and MKC-TI-175 for conversion from subcutaneous insulin to Gen-2 delivered Afrezza insulin (See above, Afrezza Dosage Chart for Study MKC-TI-171). "
    Apr 1, 2014. 01:51 PM | Likes Like |Link to Comment
  • MannKind - A Trail Of Failure Leading To Success [View article]
    Or it could just be that management is incompetent or cocky? They swapped inhalers twice during their trials. They refused to share data with the FDA that resulted in the second CRL. Now they are trying to switch dosing from what was presented in the trials. Getting insulin dosing correct seems pretty important.
    Apr 1, 2014. 11:06 AM | 5 Likes Like |Link to Comment
  • What The FDA Document Says About Afrezza: Implications For FDA Approval [View article]
    You also forget that this is the same management team that did not comply with the FDA request for inhaler bridge data before the 2nd submission. This generated the 2nd CRL. That could have been prevented if MNKD complied with FDAs request.
    Mar 31, 2014. 09:47 AM | Likes Like |Link to Comment
  • MannKind down premarket as Ad Comm prepares to discuss AFREZZA [View news story]
    I refer you to the first paragraph on page 181 of the briefing documents on T1. Technically non-inferior, but many many questions. Simply meeting primary endpoints is not a guarantee for approval.

    Page 86 on T2: Reviewer’s comment: To put these results into context, Table 17 shows the HbA1c reduction achieved in reviewed (labeled) studies of antidiabetes drugs representing various classes, studied in combination with metformin alone and at least two other OADs. While cross-study comparison is difficult and generally not recommended, on its face, the
    magnitude of the effect size achieved with Afrezza TI in comparison to these other antidiabetes agents is surprisingly modest, especially in light of the fact that Afrezza TI can be titrated."

    Page 160 on T2: "During the 24-week treatment period, the average daily basal and prandial insulin doses used in the TI-Gen2 group were consistently higher than those used in the IAsp group"
    "There may be an issue on whether insulin aspart was optimally given in the control arm"

    Page 182 on T2. "However, because of missing data, the robustness of this analysis is an issue. Since there was only one confirmatory study submitted for the indication of type 1 diabetes mellitus, this makes drawing a solid conclusion regarding efficacy for this type of diabetes mellitus problematic."

    I guess we'll see what the panel thinks tomorrow. The market is voting this morning.
    Mar 31, 2014. 09:40 AM | Likes Like |Link to Comment
  • MannKind down premarket as Ad Comm prepares to discuss AFREZZA [View news story]
    Efficacy is questionable in T1. Oral works better in T2. I'm having a hard time figuring out how this is a blockbuster?
    Mar 31, 2014. 08:44 AM | 1 Like Like |Link to Comment
  • MannKind And Afrezza's NDA Evaluation: What Is The Real Justification For The Advisory Committee? [View article]
    Puts that cost $1.50 are $1.50 per share. It costs you $150 to cover 100 shares. That's not very cheap on a stock that is sub $5.

    That being said, it probably still makes sense to cover yourself with these. It will limit the upside a bit, but protect against disaster.
    Mar 29, 2014. 11:50 PM | 2 Likes Like |Link to Comment
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