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Discovery Laboratories Inc. Message Board

mkmnymklv 147 posts  |  Last Activity: Apr 11, 2014 9:46 PM Member since: Aug 20, 2012
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  • mkmnymklv mkmnymklv Apr 11, 2014 9:46 PM Flag

    OPC:

    Thanks for your reply. Basically you agree that non linear is not necessarily bad but your concerns is: 1. efficacy related to dosing; 2. more trials for 30u,40u etc.

    Let me tell you want I know and I what I think. From the presentation AL was given, he mentioned that (could be wrong, from my memory): a. 171/175 trial used 10u and 20u cartridge. FDA does not permit higher dosage; b. some patients will need more that one cartridges and that is why initial 500 Million capacity is expected to treat 360K patients.

    To answer your question 2, why more trials. Al wants to reduce unit cost. if 30u,40u even 50u are allowed, 500 million capacity can treat 500K patients. Make sense to me. FDA can say: no, only use 10u and 20u and combine them as did in 171/175 trials, okay. Average cost will be higher, that is all.

    To answer your question 1,, efficacy related to dosage. HbA1c is not a valid measurement for efficacy although it is good for diagnosing the disease. Once treatment started, a few hypos will skew the result significantly.

    Let me quote the definition of HbA1c here below. It is a measurement of 8-12 weeks average blood sugar level. say if one has 50 (hypo) and 150, his average is 100; while the other has 70 and 150, his average is 110. They all started with 150 or the same HbA1c, even though the second person has higher ending HbA1c, the actual result is better for the second person.

    Definition:

    "The term HbA1c refers to glycated haemoglobin. It develops when haemoglobin, a protein within red blood cells that carries oxygen throughout your body, joins with glucose in the blood, becoming 'glycated'.

    By measuring glycated haemoglobin (HbA1c), clinicians are able to get an overall picture of what our average blood sugar levels have been over a period of weeks/months."

    Sentiment: Hold

  • OPC:

    When AF used 30u, his starting level was 176, dropping 104 to 72 in 57 min is great. Guess what, if linear relationship to doses exists, it needs to drop 142 to 34 (severe hypo), AF had already died (sorry AF). Non linear is good for Afrezza to patients.

    It is not important how much drop relating to doses, it is how much you ended up with because you start at different levels. Look at AF's data:

    20u, drop from 246 to 107 in 49 Minutes
    30u, drop from 176 to 72 in 57 minutes
    40u, drop from 223 to 78 in 48 minutes
    50u, drop from 282 to 86 in 50 minutes

    it seems pretty good for AF. He just needs to adjust does based on where he starts. He ended up pretty well, 70-100 fasting blood sugar level although 20u sees less for AF. You do not want linear, dude.

    Not sure why FDA wants linear relationship. It does not exit and patients do not want it.

    Any doctors on this board? Please comment.

    Holding strong.

    Sentiment: Hold

  • mkmnymklv mkmnymklv Apr 11, 2014 8:17 PM Flag

    OPC, your argument is some kind biased.

    When AF used 30u, his starting level was 176, dropping 104 to 72 in 57 min is great. Guess what, if linear relationship to doses exists, it needs to drop 142 to 34 (severe hypo), AF had already died (sorry AF). Non linear is good for Afrezza to patients.

    It is not important how much drop relating to doses, it is how much you ended up with because you start at different levels. Look at AF's data:

    20u, drop from 246 to 107 in 49 Minutes
    30u, drop from 176 to 72 in 57 minutes
    40u, drop from 223 to 78 in 48 minutes
    50u, drop from 282 to 86 in 50 minutes

    it seems pretty good for AF. He just needs to adjust does based on where he starts. He ended up pretty well, 70-100 fasting blood sugar level although 20u sees less for AF. You do not want linear, dude.

    Not sure why FDA wants linear relationship. It does not exit and patients do not want it.

    Any doctors on this board? Please comment.

    Holding strong.

    Sentiment: Hold

  • Reply to

    Bid in for $6.05

    by gesoteric Apr 11, 2014 3:45 PM
    mkmnymklv mkmnymklv Apr 11, 2014 4:24 PM Flag

    If you really think this is a strong sell, bidding at 6:05 is not smart, is it? Even with neutral sentiment at $6.41, bidding at 6.05 seems to be stupid.

    Come on. Too smart === stupid. Chances are, you will never see 6.05 and you will miserably watch this goes up, up, up all the way to FDA approval, to acquisition for 25 billion and that is about $65 PPS.

    If you do not think this #$%$ will be in double digits before the PDUFA date, you wont be here to bid for 6.05. Playing bond is much safer than 6% gain (strong sell at 6.41 while bidding at 6.05? today is not 04/01). Let me tell you, for that small 36 cents, you will most likely miss this train.

    Holding Strong

    Sentiment: Hold

  • mkmnymklv mkmnymklv Apr 8, 2014 3:32 PM Flag

    Typically, FDA will need more than 15 days to get everything done to approve a drug after the strong AdCom results. If FDA does not give 3 month extension, we should be more concerned.

    Frankly, I do not think FDA will need 90 days for the label renegotiation. If you are short, be careful, the approval could come any time in June and before July 15th.

    I agree with a lot of posters that FA is corrupted. By this hour, their special interest friends have accumulated more than 100 million shares in the past few days. Didn't you see the $12 target? Will not be surprised, if that is upgraded to $18, $25 and $30. Remember ICPT, some ANALyst even put a $350 target on ICPT.

    If you are short, be careful, MNKD could announce any partnership prior to that 07/15's date.

    Holding strong.

    Sentiment: Hold

  • mkmnymklv mkmnymklv Apr 5, 2014 12:26 PM Flag

    Two major difference.

    1. Quick onset for Afrezza. This is very crucial to the patients for meal time treatment.
    2. Convenient, Exubra;s size is comparable to a two liter Coke bottle. Afrezza is the size of a car key.

    No wonder why Exubra failed miserably.

    Sentiment: Hold

  • mkmnymklv mkmnymklv Apr 4, 2014 10:18 AM Flag

    Just wait patiently. My own DD tells me that Afrezza alone worth $25 billion upon approval, without including the value of the novel technology.

    If you look at the insert of metformin, it is supposed to be very effective for Type 2 DM. However, if you look at trial 175, one of the enrollment criteria is that metformin is not effective and patients might need some other oral pills. Afrezza did an excellent job to bring down the HbA1c by extra 0.4 that metformin had failed to do for them. I guess that is why we had a 14:0 recommendation for type 2 DM.

    How much impact? I do not know the percentage of those patients that metformin becomes less effective. However, any medicine if used over long period of time, it will be less effective. Assuming 10% and that is 3+ million patients of type 2 DM in US alone and that is equivalent of $4.5 billion sales.

    How about type 1 DM and EU and other countries? This will be A MEGA BLOCKBUSTER DRUG. Those analysts cannot think out of the box. Afrezza does not have to "woo" current customers of NOVO or LLY. Affrezza can create its own demand.

    Held through the Adcom meeting. Will hold again through FDA approval + acquisition.

    Sentiment: Hold

  • Reply to

    FDA Outcome scenarios on 15th April

    by netkwork730 Apr 2, 2014 12:04 PM
    mkmnymklv mkmnymklv Apr 2, 2014 12:24 PM Flag

    Agree with most of your points but do not think there is 10% chance of CRL. For the 13:1 and 14:0 Adcom vote, FDA will not say "no".

    90% chance of approval on 04/15, PPS beyond $15
    10% chance of delay due to labeling negotiation, PPS $2-$15 (approval in the bag)

    After Approval:

    Partnership, PPS $30
    Acquisition, PPS $60, this will be a $25 billion worth of company just for the technology.

    Holding strong on 03/31 when we touched $3.95, will hold again until either partnership or acquisition.

  • Reply to

    lung cancer concerns

    by jhnnylikes Apr 1, 2014 4:08 PM
    mkmnymklv mkmnymklv Apr 1, 2014 4:12 PM Flag

    True, it is a novel way of drug delivery.

    Sentiment: Strong Buy

  • Reply to

    one AF comment at live blog

    by chenxin0827 Apr 1, 2014 3:09 PM
    mkmnymklv mkmnymklv Apr 1, 2014 3:39 PM Flag

    no need to replace the needles. Getting 25% of the market will already reach 10 billion sales.

    Sentiment: Hold

  • mkmnymklv mkmnymklv Mar 30, 2014 1:21 PM Flag

    Agreed pfe.

    Basically for T1 DM, the FDA asked two sets of questions:

    1. Dose related. 1:3 ration and a safe starting dose
    2. Interpreting primary end results of 171, hba1c, drop out rate, missing data

    I clearly see the approval is in its way. The FDA briefing document has also proved that AF is a liar, so is summer street.

    Holding long strong.

    Sentiment: Hold

  • They were able to cover at the sub $4, "good" work for those who sold out of being panic. Shorts covered, those need a position got a position. Those who bash had a reason, either get in cheap or cover cheap. If they think this is a trash, they would not waste their time here. Period.

    What's next?

    1. Adcom will vote to approve,
    2. FDAwill approve,
    3. Al will sell this #$%$ for 25 billion.

    Holding strong until 7/4/2014

    Sentiment: Hold

  • Reply to

    MNKD- Opinion

    by ricemba1965 Mar 28, 2014 7:02 PM
    mkmnymklv mkmnymklv Mar 28, 2014 7:47 PM Flag

    Same thoughts here. Have read both versions of the brief documents, got a feeling that FDA will approve both 1 & 2 DM.

    First safety, no one has any issues from all three FDA teams. The transient coughing is not a show stopper. Neither the drop-out rate. I do not have the number handy but I won't be surprised that the drop out rate for Novolog during its phase 3 trial would be even higher when first introduced.

    Efficacy for DM2, no question asked.

    Efficacy for DM1, here I hear two voices from FDA. Once voice says the primary end point is met. The other says not "non-inferior", hmmm.

    Well, during the trial design, FDA demands "non-inferior" and that is measured by the hba1c within 0.4 difference with 95% CI. all FDA groups admit that 171 does meat this primary end point.

    put things in perspective, With so many fewer hypos in the TI arm, hba1c difference of 0.4 is expected. if you really measure the blood sugar level 24 hours for 26 weeks, I am sure Ti is better than Novolog. And guess what, blood sugar level is the parameter those patients need to be careful.

    if WE (FDA, ADcom committee, investors etc) all put patients above everything else, we would like to give those who are suffering another choice. Real life performance of a drug cannot be measured in lab settings and trials. Just take into consideration of patient compliance, the 0.4 diff would be easily wiped out by a single miss of dose due to non compliance.

    Holding strong.

  • Reply to

    Put this date on your calendar longs 04-04-14

    by yocoo3699 Mar 27, 2014 2:25 PM
    mkmnymklv mkmnymklv Mar 27, 2014 4:19 PM Flag

    4x4+14=30, good call.

    Sentiment: Hold

  • mkmnymklv mkmnymklv Mar 27, 2014 12:24 PM Flag

    Same thoughts here but I'd rather think those who know something is covering, rather than accumulating. Not too long ago, the pps was $2 and quickly climbed to $6. Those who shorted was hoping the pps back down but that never have happened. The were deliberately holding down the price, hoping to cover. Looks like those short never had a chance to do that without a loss. a favorable vote would bring this up to $30 range and the approval will take it to $50.

    Holding my shares strong.

    Sentiment: Hold

  • mkmnymklv mkmnymklv Mar 27, 2014 10:51 AM Flag

    Hmmm,

    Not sure you are joking or it is real. But regardless, if I were you, I would not sell at 4.87. If you have held thus far you might just wait and see.

    Dealing with FDA is the pain on the butt. it is true binary event. If ADcom nay it, you may be cut by 2 more dollars. However, if Adcom brief doc is good and the voting is good, you will be awarded with 10+ gains short term and 30+ gains long term.

    Let's do the simple math, the MLV article says $3 billion sales (2 billion cartridge capacity next year). That is 10 billion cap conservatively. with 400 million shares, it translate into some 40 pps.

    Not surprised that AL will sell this for 25 billion.

    Holding strong.

    Sentiment: Hold

  • Reply to

    I really love the future market cap of mnkd

    by goldmato Mar 23, 2014 4:33 PM
    mkmnymklv mkmnymklv Mar 24, 2014 4:37 PM Flag

    Agreed

    12+ million shares changed hands and price holding steady in a widely down day for Bios, does not sound like anything negative. Rather, it is more likely someone is accumulating.

    Sentiment: Strong Buy

  • Reply to

    2 Out Of 3 Material Events Are Done & Known

    by kevinmik Mar 19, 2014 3:42 PM
    mkmnymklv mkmnymklv Mar 19, 2014 4:31 PM Flag

    Maybe to only few people that can be counted by numbering the fingers in one hand. To them, they got in so cheap and they do need to thank Ms Yellen. But regardless, $3 billion shares projection equals $20 billion cap and that is $55 PPS.

    Sentiment: Strong Buy

  • Re-read the SA article by the MLV guy. He is talking $3 billion sales and $9 target. But neither has a timeline. Let's take the $3 billion sales (although very conservative already), it translates into $20 cap or $55 PPS. Is this guy thinking of $9 pps before the Adcom and $55 pps post approval?

    Sentiment: Strong Buy

  • to go to da moon. last call, catch it or miss it.

    Sentiment: Strong Buy

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