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  • MNKD Comparison To NKTR Going Into Adcom Review And Beyond 13 comments
    Mar 23, 2014 8:27 PM | about stocks: MNKD, NKTR

    Hello again, for those who are not aware my screen name on yahoo message board is alfredamus and recently my outlook on MNKD near term prospects have changed due to the recent Sec filings released on Mar 3rd - 4th which indicate MNKD anticipates, for reason not revealed, the need to raise more capital. I recently made some posts on YMB which stated the reasons for my change in perception and will paste some of them below to save time of typing them out here. But first I decided to write this article as a follow up to last one so those who do not follow YMB will know I now have a different perception going forward for which they can take into consideration and YMP does not allow for posts that are this long.

    This blog is my opinion only and is not a solicitation to buy , sell, short any of the stocks mentioned.

    In previous posts on YMB and comments I made to Scrying Biotech article which compared 5 other bio tech stocks that had adcom reviews, I made mention that PFE and exubera was actually only company and drug worth comparing MNKD and afrezza to but overlooked Nektar Therapeutics (NASDAQ:NKTR)whom PFE partnered and jointly developed exubera with.

    NKTR actually may be a better comparison as market cap a week before Exubera Adcom date was very close to what MNKD MC is right now a week before Afrezza Adcom review, just over $2 bil. Also the real comparison that is pertinent and reason for my change of short term outlook for MNKD hinges around the difference between having a BP partner as NKTR had with PFE and MNKD whom has yet to obtain a partner. I will refrain from comparing the two drugs and inhale devices as everyone and their dog is aware of those differences which have been writen about many times and possibly will be mentioned again in comments to this article as well.

    From Aug 30th close of $16.55 NKTR closed up about $1 two days before Adcom at $17.33 and almost up $3 day before closing at $19.14, was halted day of Adcom and up slightly over $3 day after Adcom closing at $19.59 after panel voted for approval for both type 1 and type 2 diabetes as they voted twice 7 to 2 for approval on each indication. Less than 2 weeks later NKTR pps gave up all those gains and on day FDA announced 3 month delay on Oct 28th "while it reviews chemistry data on the diabetes treatment" shares hit a low of $13.63 and closed at $14.66 then rebounded a week later to $16.11 and eventually climbed all the way back up to $20 before FDA approved exubera on Jan 27 2006 but never run higher than close of $21.76 on Feb 22 and gradually fell back to a close of $16.76 on July 25th day Pfiser announced launch delay involving educational and manufacturing hurdles.

    "Pfizer said it would delay the launch of its inhaled insulin Exubera until early September, weeks later than its previously anticipated delivery date of mid-July. Pfizer executives said Thursday in a conference call with analysts the delay is a result of wanting to make sure US educational programs for doctors, pharmacists and diabetes educators are properly conducted. "We will never get a second chance," to introduce Exubera, said Pfizer CEO Hank McKinnell. Pfizer vice chair of human-health, Karen Katen, said, "our education programs and manufacturing preparations are time consuming but we are taking the time necessary to do the job right. We are working not only to meet initial demand for the medicine but also continued demand from prescription refills. Initial supplies of Exubera will be available across the US beginning in September."

    Fast forward to Oct 2007, PFE officially pulled the plug on Exubera on Oct 18th 2007 NKTR closed at $8.08 day prior on the 17th and at $6.67day of the announcement and eventually hitting a low of $5.22 a few weeks later on Nov 7th. With PFE's decision to pull Exubera from market, NKTR was paid $135 mil from PFE and given the right to market exubera and or partner with another company to co-market exubera but to date NKTR has yet to do so. It seems NKTR has moved on with a product pipeline that consists of drug candidates in various therapeutic areas including oncology, pain, anti-infectives, and immunology and has various license, manufacturing, and supply agreements for its technology with biotechnology and pharmaceutical companies, such as Affymax, Amgen, MAP Pharmaceuticals, Merck, Pfizer, Roche, and UCB Pharma. NKTR closed at $13.44 on Friday and is awaiting its own Adcom Review which was recently rescheduled from this month till July.

    Some of the early founders of NKTR are now pursuing a different version of inhaled insulin in a liquid form transformed into a mist by their pocket sized inhaler under a private company by the name Dance BioPharm located in San Francisco Ca as is NKTR. Dance is likely a minimum of 5 years behind MNKD in reaching market and its future could possibly depend on how Afrezza fares in next few weeks and performs in market should it gain approval and obtain a partner.

    Historical quotes in article provided by Yahoo showing price pattern for NKTR on or around pivotal dates mentioned above.

    Now that NKTR previous history has been detailed, below I present some previous YMB posts explaining reason for my reversal on short term outlook for MNKD. I wont include all of them as those who wish to read all of them can do so by going to YMB and click on my screenname.

    alfredamus • Mar 20, 2014 4:09 PM

    The signal sent obviously was perceived as negative as share price was well over $6 looking like it was going to run into adcom when filings hit and now $6 seems to be strong resistence. Whether correct or not the fact is investors have the right to know the reason MNKD needed the extra funds especially when the implications of the filings seem to suggest a possible delay of some kind is possible. Seems many here are ok with being given just half the story and then speculating with unending optimism that such filings do not signal something quite possibly detrimental to their position. I perceive the filings and stock price afterward over last 2 weeks signaling that there may be telegraphing a possible delay could occur and investors are always the last to find out.

    alfredamus • Mar 20, 2014 4:44 PM

    For what it's worth and for those who are not completely blinded by their stock positions, LLY's latest diabetes drug was rejected on Mar 5th due to manufacturing plant not being up to FDA specs just a day after MNKD filed for $50 m stock offering. The delay is estimated to delay fda approval by 6 months and cost $450 m in lost revenue and upgrading plant. I would also bring to your attention that exubera launch was delayed about 6 months after FDA approval in part due to manufacturing setbacks. I mistakenly thought prior to this post that the 3 month delay between Adcom vote to approve exubera and actual FDA approval was due to manufacturing delays but that 3 mo delay was so FDA could examine data relating to lung function for most part. That said and so far PPS seems to confirm, many investors seem to think the filings could telegraph a delay of some kind and I for one think if such a delay does occur it very well could be related to manufacturing end of things. If anyone has a better explanation for MNKD raising more capital when they have enough to take them at least till Sept and why they would need more $ if partnership negotiations were actually something to be very happy about prior to filings, I think we would all like to know.

    alfredamus • Mar 20, 2014 7:39 PM

    A partner would however make an upfront payment in neighborhood of $500 m which if a deal was on the table to be announced next month upon approval as most here anticipated there would be no need to arrange funding which costs a lot of money and cause dilution compared to using the upfront payment untill revenues are generated at which time revs would foot bills. The additional funding is worrisome and share price confirms this.

    alfredamus • Mar 22, 2014 11:23 AM

    This comment below M Pfeffer made just hours before DF restructure filing and day before $50m offering,surely isnt a comment one would expect he would make knowing these filings were to follow and I find the comments deceptive being no mention of the other pertinent info was made but instead was delivered afterward. "I dont expect to need it" he states so then why go to all the trouble and expense to raise even more $ several months before even possibly needing to draw this $30m and sink the share price in the process. You would think they would of a least waited for adcom and pdufa results which if positive would of increased chances of an likely $500m upfront payment from a potential partner. Many have tried to smooth this over but like many of Rapp78 counter points the arguements dont hold water when measured up against the facts. DerekL understands and a few others but some of you obviously want to believe what your position in stock leads you to believe just as Rapp will try to continue to support some of his claims despite having been proved wrong. Maybe some of you need to reread Scrying Biotechs last article and the part about how certain beliefs influence your decisions.

    "We do still have $30 million available under our line of credit from Mann Group. Remember that was originally a $350 million line, but we've converted and we've paid back in the interim. So we have $30 million available. We are just going to keep in that as a little safety margin. I don't expect to need it or I hope not to have it drawn it, but it's nice to have it there."

    I will end the previous YMB posts there, I also made comments on most recent articles by George Rho and Black Gold who wrote about Deerfield restructure and conversion which clearly expressed my concerns about timing of MNKD releasing the filings before Adcom and PDUFA dates and how ticker tape since filings seem to confirm my concerns which many have already read. As I tried to explain then,what DF may or may not have done with converted shares pales in comparison to why MNKD needed to raise more capital at this point in time when they stated they had enough till 3rd qrt, instead of waiting till after Adcom and PDUFA dates and closer to 3rd qrt should no partnership deal materialize by then and additional funds be needed.

    I do not claim to know what will transpire at Adcom or what FDA will decide or why MNKD decided to raise capital when they did but I did exit my long position in the stock day after SEC filings due to what the possible implications of the filings as I percieved them to be and how I speculated the market would perceive them. Also as YMB post above suggest, I found it a bit unethical that management would lead investors to believe their cash position was in check without a word of futher funding in either earnings CC or Cowen conference the very day / day before the filings came out.

    One last thought to consider before I wind this article up as I never mentioned it before but its been in back of my mind for awhile. The decision to switch to DB inhaler has delayed Afrezza from being leagally used by diabetics a couple years and cost MNKD and investors millions perhaps hundreds of millions even billions when potential lost revenues are factored in. In hindsight, it would seem that the decision to switch inhalers was not the best decision and tho Medtone inhaler had a few disadvantages it likely would of been approved as there would of been no 11th hour presentation by the Skherli Hedgefund shorty and at least would have offered diabetics an alternative until the DB proved bioequivilent to Medtone inhaler if MNKD still wanted a new and improved inhaler. i.e. the several new and improved insulin pumps approved since Medtronics bought Dr Mann's insulin pump over a decade ago.

    That said, though my short term outlook for MNKD is anything but rainbow and lollipops currently due primarily to not having a partner and my speculation partnership negotiations are not going as "happily" as management suggested previously, MNKD like NKTR could have a brighter outlook long term with all the other patents they own regardless what afrezza outcome is, tho I wouldn't want to consider how long potential waiting period might be without Afrezza being successful or if MNKD needs to go it alone. With that I wish all longs and diabetics wanting an alternative choice the best of luck. Let the comments begin !

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Stocks: MNKD, NKTR
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Comments (13)
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  • homerun
    , contributor
    Comments (88) | Send Message


    While a delay is entirely possible, I don't think the stock offering is a red flag nor do I view MP's comments as "deceptive." That's a little over the top. It's safe to say the offering is a small insurance policy in the event the FDA pushes the decision date back or sticks them with a manufacturing stipulation. Personally, I believe management is covering all the bases here. The timing isn't necessarily questionable either. It's more prudent to raise capital in the event of a delay prior to a potential delay rather than scurrying around looking for additional capital after a delay. Everyone knows MNKD's balance sheet is nothing to write home about. Al is the ultimate backstop anyway. It's difficult to see Al cutting bait with a positive ADCOM and a billion into the venture up until now. The fact that MNKD has yet to partner is far less significant than the eventual outcome of the ADCOM and the FDA's final decision. If the FDA green lights Afrezza, a deal will be struck and the flood gates will open.


    Disclosure: I'm long MNKD.
    23 Mar 2014, 09:32 PM Reply Like
  • VerticalView
    , contributor
    Comments (255) | Send Message
    Author’s reply » Homerun, you make some some sense when it comes to It's more prudent to raise capital in the event of a delay prior to a potential delay rather than scurrying around looking for additional capital after a delay but the flip side is what worries me. MNKD did not elaborate on reasons for raising additional funds and that is a concern that they could actually anticipate a delay is on horizon vs a just in case scenario. Time will tell for sure but the filing and ticker seems to be hinting something might not be as "happy" as previously suggested at least when it comes to partnership negotiations. I think when it comes to the perceived potential of Afrezza by many and the fact no partner has stepped up to plate so late in the game with a contingent offer is hard to rationalize and tho adcom and fda approval is more significant, should approval take place there is no guarantee a deal that is agreeable to both parties will materialize perhaps until afrezza proves to generate blockbuster revenues. This leaves door open that maybe MNKD anticipates going it on their own thus the need for raising of capital.
    23 Mar 2014, 10:08 PM Reply Like
  • OmahaPaul
    , contributor
    Comments (24) | Send Message
    If you base your investment decisions based upon what other investors do, you will always be a "follower" never a "leader" in the market. Therefore, your returns will always be suppressed, which in return in return gives you a worse risk/reward ratio on your investments. That is why Warren Buffet says be "Fearful When Others Are Greedy and Greedy When Others Are Fearful".


    Yes, there are many investors who having failed to do an in-depth due diligence are fearful of MNKD. Yes, the PPS indicates that. What does that mean though? It means for those who have done their due diligence, it is time to be "greedy".


    This is a low risk, high reward investment. Based upon the potential for the PPS to more then double within the next 30-60 days, it provides the potential for an exceptional annualized ROI.
    24 Mar 2014, 12:20 AM Reply Like
  • OmahaPaul
    , contributor
    Comments (24) | Send Message
    Your entire argument seems to be based upon pure speculation and by ignoring many different facts. First, you failed to note that it is "in fact" very common for companies to take actions to raise additional capital prior to a binary event. In this case, however, no capital was raised. Only the possibility. What we do know for a fact is: any dilution associated with the SEC filings, if both DF converts another $60 million as well as the additional $50 million ATM being executed, is minimal.


    However, you seem to believe that management should be negligent, and not prepare for all possibilities. That in fact would be irresponsible of management. In addition, since Deerfield is looking at a debt to equity swap, that action may be seen as a positive. Upon execution, Deerfield would no longer be paid any further interest on that portion of the debt. Since many have complained about the amount of debt on MNKD's books, it seems like steps on their part to clean up their balance sheet should be seen as a positive. Plus, any experienced investor would certainly be making projections of future PPS based upon 450 - 500 million shares outstanding. Even if Deerfield converts, and the new ATM is executed, you are only looking at a little over 400 million shares.


    You also fail to mention that Alfred Mann the CEO, who has invested over $1 billion of his own money in MNKD is known as a very tough negotiator. In fact 18% of biotechs do not sign a partnership agreement until post approval, and per published articles those that have the funds to wait till that point in time are able to negotiate better terms. In fact, at least one published article recommends biotech companies do so if at all possible. Therefore, long term the shareholders generally benefit if management wait till post approval to agree to a partnership. You also imply MNKD will receive $500 million on signing of a partnership, which might not be true. Why? The reason being, you failed to mention that MNKD's management has stated on several occasions they are looking to negotiate a deal with a smaller upfront payment in return for a larger royalty payment.


    Generally, those that write and perform objective, high quality analyses present both the pros and cons to different actions and the known information. However, you failed to do so. That indicates a subjective view on your part, that you then tried to find a way to support. Therefore, no investor can assume your analysis has any credibility, or give it any type of serious consideration. In fact, it is rather amusing that you claim your viewpoint is not subjective, but then try to imply that everyone that does not agree with you must hold subjective viewpoints and be blinded. In my opinion, that appears rather egotistical on your part.


    As for myself, and like many investors I suspect, I have performed a detailed "root cause analysis" of why no partnership has currently been signed. In doing so I have considered all the negative and positive reasons published by both medical/scientific and investment professionals as well as reasons expressed by amateurs such as yourself. I am not using the term amateur here as a term of disrespect, just to indicate what your level of skill is based upon your own profile. I have also identified, and added to the root cause analysis, many items which have not been mentioned in any of the published articles but which due diligence and research should have identified. Again, since you seem completely unaware of those items, that would imply that you have failed to do any serious, in-depth research of your own on this matter. That again implies a lack of objectivity on your part.


    So the question then becomes, why do you feel the need to write and have published such a subjective opinion? It seems the person you are trying to convince is yourself. While there is never any guarantee as to the outcome of any future investment, right now the clinical data and information available strongly support that FDA approval is likely. However, even if delayed for a short period of time due to manufacturing issues as you imply might happen, that would not result in a loss for longs. Independent physician surveys indicate they would prefer a faster acting insulin, and in fact would prescribe Afrezza. Based upon the clinical utility of Afrezza over existing insulins, if it is priced similar to existing prandial insulins administered via pens, then tier 2 payer support should be easily obtained. Most important; many different independent surveys of diabetics indicate they strongly would prefer an inhaled insulin which strongly would indicate that Afrezza will achieve blockbuster status when commercialized.


    In addition, the technosphere platform may provide the opportunity for a big pharma partner to utilize it to develop newer inhaled versions of some of their other, current blockbuster drugs that are coming off of patent. Including such things are common in partnership agreements where the biotech company does not just have a single drug, but has a platform.


    Since big pharmas are in the business to make money, what seems much more logical then your analysis is that MNKD is demanding and holding out for the very best partnership terms possible. They understand the value of what they have, and are not rolling over and signing a less then acceptable partnership agreement just to mollify weaker investors. This means, even under the best of conditions, it would be more likely that a partnership agreement would not be reached until post approval. It is not because MNKD is negotiating from a position of weakness, but because they are negotiating from a position of strength. Something you do not seem to understand, but more astute investors who have done their due diligence do.
    23 Mar 2014, 11:29 PM Reply Like
  • VerticalView
    , contributor
    Comments (255) | Send Message
    Author’s reply » with that perspective why then has there yet to be a contingent partnership deal on the table so late in the game. I need to run for now but will reply more later. Thanks for the comment.
    24 Mar 2014, 12:49 AM Reply Like
  • VerticalView
    , contributor
    Comments (255) | Send Message
    Author’s reply » OP, regarding "In this case, however, no capital was raised" I think there is some speculation and assumptions being made on your part as you have no way of knowing whether MNKD has actually raised funds or not. Do you think the recent SA article that interviewed the MLV exec followed by a big spike in volume the very next day was something that was by chance ? The stock whip sawed all the way to $6.20 and back closing just pennies higher for the day. I cant say for sure but it is my best educated tho speculative guess that it was not by chance this happened.
    Regarding your statement "any dilution associated with the SEC filings.... being executed, is minimal. However, you seem to believe that management should be negligent, and not prepare for all possibilities. That in fact would be irresponsible of management".
    All I can say is what I tried to tell G Rho and Black Gold which is that is secondary to the perception of what the filings suggest which is negotiations may not be going as happily as management has stated previously. When it comes to "irresponsible" wouldn't you consider management not making one mention of the filings the very day the 1st one was released irresponsible ? I do and I'm not the only one I assure you.
    Then there is this comment "You also imply MNKD will receive $500 million on signing of a partnership, which might not be true. Why? The reason being, you failed to mention that MNKD's management has stated on several occasions they are looking to negotiate a deal with a smaller upfront payment in return for a larger royalty payment."
    M Pfeffer if memory serves me correctly used $300 to $500 mil figures as an example of a smaller upfront payment in one of the conferences a couple months back. That said If partnership negotiations were going well as management has been alluding to lately by saying they are "happy" with Greenfields progress, why then the filings which would be unnecessary if upfront payment in that range was forthcoming upon approval as many anticipate. Lets be real, how "happy" can management really be when Greenfield has yet to land a contingent offer by any of the potential suitors. Perhaps Exubera debacle has potential partners waiting not only for approval but for afressa to prove itself in the market place as well. NKTR could of made changes to inhaler and tried to find another partner but never did but despite your detailed " root cause analysis" you failed to mention that fact. I am going to leave it at that for now and let the ticker tell the story. Good luck
    24 Mar 2014, 03:06 AM Reply Like
  • OmahaPaul
    , contributor
    Comments (24) | Send Message
    Unless a potential partner is willing to pay substantial, non-refundable money upfront for a "contingent partnership deal" with all royalty terms desired, there would be no value for MNKD in agreeing to one. You don't stop negotiating with other interested parties just because someone agrees to your terms with a big "BUT" or a big "OUT". That would be silly for MNKD to agree to.


    In addition, since MNKD is operating from a position of strength as supported by a very strong majority of the known facts, then the terms they are requesting would be such that potential partners would wait till post approval to come to final terms. Just because potential partners wish to minimize risks on such a big investment does not mean there is reason for concern.


    Based upon research, the potential partner is likely looking at spending somewhere in the range of $1.5 - $2.0 billion dollars on this deal in the first two to three years. So a potential partner waiting post approval to finalize terms is good risk management on their part.


    However, no one says potential partners are not going to try to play their games as well. They are certainly not new to this game either. That is why the potential increase in additional capital helps strengthen Al's hand in negotiations even more. Plus, any reasonable analysis indicates there is at least two, if not more big pharmas, that should be extremely interested in an Afrezza marketing partnership with MNKD.


    Another item, it also insures MNKD has the capital to order the next capex expansion of the Danbury plant immediately upon FDA approval if so desired. Due to the lead time on the new production lines, this is critical to accelerating sales growth. After all, the initial three lines will only support about $600 - $700 million in annual sales at max.


    For those who then state that Al is TOO tough in negotiations, that is also not supported by the facts. Al has sold many prior companies and was able to come to terms on those assets. Whether buyout or partner, Al has shown the ability to negotiate and come to agreement on major transactions. A good example is his $100 million contribution to different colleges. UCLS turned down the money as well as other universities, but USC and Purdue did not. The truth is, Al has demonstrated he is an extremely skilled negotiator over his lifespan.
    24 Mar 2014, 03:49 AM Reply Like
  • natepile
    , contributor
    Comments (13) | Send Message
    Thanks for the update, VerticalView!


    The question, of course, remains "is Al bluffing, sitting on a 'decent' hand... or slow rolling the entire table after all he's been through?"


    I suppose we'll find out soon enough!


    Thanks again for your contributions to helping investors consider as many sides of the story as possible as they place their final bets!
    24 Mar 2014, 12:34 AM Reply Like
  • Turk_74
    , contributor
    Comments (4) | Send Message
    I don't know either but, 'not so fast' or 'rome wasn't built in a day' may be the watchwords VV. Your skepticism seems to built on an assumption there is something that management knows but is not disclosing. On that front, one interpretation of being happy with Greenhill's progress might just be that MNKD is pleased there are several bidders for partnership at the table, but not taking final bids until after approval and some definition of label. If that is the case (and I think it may be), then in addition to potential delays for the PDUFA date itself, if you subscribe to the theory that a partnership deal will not be struck until after PDUFA, it is highly likely there will be some time needed post PDUFA for bidding for the deal and making that deal and papering that deal and possibly some need confirmatory business due diligence or legal due diligence which has not been conducted yet......and then closing that deal.....and this takes time.....60 days, 90 days, 120 days??.......and having extra cash on hand for not much dilution can fill that void too if necessary
    24 Mar 2014, 03:51 AM Reply Like
  • VerticalView
    , contributor
    Comments (255) | Send Message
    Author’s reply » Turk... your view on what happy might mean is a good as any I suppose as we really can only speculate what degree of happiness MNKD is expressing and they are bound by confidentiality agreements as to what can be said when it comes to partnership negotiations and pilot fish mentioned loose lips got them in trouble last time around. That said MNKD has been seeking to Partner up for several years and not one BP has stepped up to plate with even a contingent offer that would protect them from potential delays should adcom or pdufa results prove negative.
    Recent ph 3 results and Greenhill havn't changed this pattern as of yet so the argument some are making that MNKD is biding their time and is in a position of strength and raising more funds is a good sign etc is hard to buy into for me anyhow. That said many say a favorable adcom and FDA approval will do the trick and that seems plausible but will it do the trick ? Considering no contingent offer has been made to date after several yeas could BP be over cautious due to PFE having been burned so bad on exubera and the fact no one partnered with NKTR either after they were given full rights to exubera, perhaps BP is waiting to see how Afrezza does in market before committing hundreds of millions. Could MNKD be anticipating such a scenario and lining up funding to launch afreeza themselves ? A couple posters on YMB have suggested this could be the case and it would take about $100 m to do it according to one mnkd long. Below is this posters response to a post I made on YMB


    dereklinders • Mar 20, 2014 5:04 PM


    I agree. Of course, I believe that no major pharma will touch Afrezza for at least another 18 months. In the meantime, MNKD will need to use the services of a large distributor like AmerisourceBergen.


    Launch under this scenario would require another 100M of dilution.


    Yet here I am, long (but hedged).
    24 Mar 2014, 01:57 PM Reply Like
  • Keith_69
    , contributor
    Comments (177) | Send Message
    To me (and I will say it) comparing this to Exubera is just silly at this point. Like comparing a lemon to a peach. And as for no partner, why would someone sign a partnership or announce it prior to FDA approval. Without approval, there is no product. So if a big pharma was to sign on and they announce it, it could bode poorly for both is FDA approval is not given.
    Also to note, why would you 'taunt' the FDA acting like it's all but done by announcing a partner, perhaps announcing packaging labels, talking about markets....that kind of thing shows great hubris and I am sure the FDA would not take kindly to it.


    I believe what is happening is this, they are like professional boxers, after a fight, knowing in their heart they won, it is not until the announcement that they put on their <insert sponsor name> hat before getting in front of the camera/public.


    To me this is just common sense/good business. I expect if they get FDA approval (no delays) then you will see a FLOOD of announcements.
    24 Mar 2014, 09:32 AM Reply Like
  • pilot fish
    , contributor
    Comments (147) | Send Message
    Keith. We'll said. They had loose lips before the last CRL from the FDA and it cost them a lot of cash. They got critized for this by everyone and now they are getting critized for not talking?!
    24 Mar 2014, 10:53 AM Reply Like
  • VerticalView
    , contributor
    Comments (255) | Send Message
    Author’s reply » Keith....partnerships take place all the time before the pdufa date tho usually well before a few weeks before and FDA isnt supposed to consider such things as their main concern is safety and efficacy. That said BP statistically have higher approval rate than small bios.
    24 Mar 2014, 12:23 PM Reply Like
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