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Synta Pharmaceuticals Corp. (SNTA) Message Board

dtrouble1003 369 posts  |  Last Activity: Apr 13, 2014 7:24 AM Member since: Jul 26, 2011
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  • dtrouble1003 by dtrouble1003 Mar 10, 2014 12:51 PM Flag

    Follow the smart money

  • dtrouble1003 by dtrouble1003 Feb 4, 2014 2:22 PM Flag

    FACTS:
    1) Afrezza is the fastest acting insulin in the world today.
    2) Afrezza's PK/PD properties are far superior to anything on the market today.
    3) In clinical trials Afrezza showed statistically significant benefit in Hypo events vs Novalog
    4) Afrezza met primary endpoints in two PIII clinical trials designed and coordination with the FDA in a SPA
    5) Afrezza has been shown to be safe and effective in over 6000 trial participants, showing no clinically significant impact on lung function or lung cancer risk.
    6) MNKD has a tentative ADCOM meeting scheduled for April 1 and a PDUFA date of April 15.

    Fiction:
    1) Afrezza is just like Exubera and will suffer the same poor sales as Exubera. (they are jumping to sales already)
    2) Afrezza causes lung cancer ( statistically in diabetic populations trial participants actually had fewer incidents of lung cancer compared to untreated patients)
    3) ADCOM is a terrible sign for the possible approval of Afrezza (do we need to even list all the examples of successful marketed NDA currently on the market that had an ADCOM?)
    4) FDA is concerned about lung function (where how when did they ever say that?)
    5) MNKD will never be able to find a partner (pure speculation)

    I wonder who is suffering from group think? Seems to me Longs have a much stronger position. Please feel free to add and subtract MNKD Longs.

    In my mind the only risk is corruption by the FDA, but that isn't any better based in fact than any other short thesis.

  • 1) nothing has changed
    2) Type I and Type II approval
    3) FDA will require post approval study and or monitoring to follow FEV and Lung neoplasms which I expected all along
    4) Label warning for Diabetic Ketoacidosis and retinal detachment.
    5) Label warning against use in COPD but that isn't a guarantee based on comments:

    In conclusion, the available data from clinical pharmacology studies for AFREZZ does
    not conclusively support use in patients with underlying lung diseases. The data from
    clinical studies will be considered along with the available limited PK results to develop
    the final labeling recommendations.

    Might recomment tighter monitoring if used in these patients.

    From FDA doc:

    Reviewer’s comment: Overall, the results of these analyses suggest no difference in safety
    between Gen2 and MedTone except for a higher rate of cough and dyspnea, with some
    events leading to dropout, with the Gen2 device. One caveat is that there are small
    numbers of events limiting conclusions. Given the small numbers, and because objective
    data is more sensitive and specific for picking up differences in safety issues compared with
    adverse event reporting, more weight should be given to review of the spirometry data in
    comparing pulmonary safety between the two devices.

    NOTHING HAS CHANGED

  • You morons are allowing the shorts to cover cheap. This is a buying opportunity if there ever were one. I bought more this morning. You should to the same. Don't allow these BAS$#Ds to scare you into believing that this is more than it is. They are negotiating labeling and post marketing studies.... end of story.

    I have never been more confident in the future of MNKD

  • First let me say I think its great that progress is being made on oral administration of Insulin. I believe ORMD with its liver first pass metabolism mechanism of action is making progress. However:

    Cmax
    was reached at an approximate 100-min lag from start of meal
    (Table 1, range: 60-150 min),

    In all cases, insulin levels returned to baseline within 45-300 minutes of peak recordings,

    ORMD-0801 offers no advantage in pharmacodynamics over afrezza what so ever. (afrezza cMAX 12 minutes, clearance 90 minutes) Though much has been made to compare Afrezza and ORMD-0801 there only similarity is that they are an alternative to needle injections. Its obvious to me that ORMD-0801 will in fact become the needle alternative for long acting insulin administration. Together MNKD and ORMD will offer the only completely needle free treatment of diabetes. In short MNKD and ORMD will never be in direct competition because MNKD is far superior in its pharmacodynamics for meal time insulin.

  • Reply to

    A few things of interest if you're interested :)

    by matese16 Apr 7, 2014 3:29 PM
    dtrouble1003 dtrouble1003 Apr 7, 2014 4:45 PM Flag

    I agree with you Matese16. People forget that a three month delay can actually be beneficial for MNKD too since they will have input on the final label in NEGOTIATIONS with the FDA. This may give them enough time to actually negotiate a more favorable label than if it were rushed through.

  • As a researcher in BP I can't tell you how many times I've been approached with rediculus theories about big bad pharma having the cure for cancer, or possessing unethical political influence on government agencies like the FDA. I can assure you that BP does not have the cure for cancer. I would also say that the vast majority of CRL's go to BP too since the majority of NDA's come from BP. If they do have influence on the FDA they need to work on it.

    Regarding some over-whelming fear on the part of BP for the immediate domination of Afrezza and its immediate impact on their bottom line, I don't see that either. The diabetic market is huge and growing and there will be plenty of space for another player. Could Afrezza be a dominant player in the space eventually? Sure... and I hope they will, but BP will have planty of time to assess its progress and make an offer that cant be refused by MNKD where both parties profit. It would be huge for Afrezza to achieve 1 billion in sales and the impact on MNDA stock price would be immence, but guess what? There is another 14 billion being made in the same diabetic market. (I cant remember off the top of my head what the estimated market size is).

    The FDA and BP scientists are working every day to find a cure, to protect the public, to make the world a better safer, and healthier place. That is my first hand experience. Is there any possibility of curruption? Of course there is. I too have had this fear but a level head devoid of conspiracy theories points to a more sane interpretation of the truth.

  • dtrouble1003 by dtrouble1003 Mar 15, 2014 12:24 PM Flag

    Response to Rapps moronic supposition about FEV changes relative to doses required to achieve A1c. I refuse to correspond with this moron directly.

    If you perform a safety study over two years assessing FEV and A1C the number of doses relative to FEV changes is measured by the standard error calculated for each data point.

    If as you postulate half the patients required twice the doses of the other half to achieve the same A1C poses a safety risk the error bars would be significantly large to suggest a trend. The error bars are very tight over a large sample population and hence the difference between a single and multiple dose is minimal.

    I will not respond to your equally moronic rebuttal. Go back to whatever it is that you do well, if anything, because science isn't your gig.

  • So I added at 5.98

  • Reply to

    Longs who sold yesterday....

    by rambleon_12 Apr 1, 2014 8:18 PM
    dtrouble1003 dtrouble1003 Apr 1, 2014 8:40 PM Flag

    Anyone who says they were not sick to their stomach yesterday and all day today is fos. I have done great DD in the past and still got it wrong. We are on the right side if the trade today. 70% dd 30% luck. I feel for the guy. Be grateful for our good fortune. Good luck you all and him in the future!

  • Reply to

    Afrezza works much better than trial data!!!!

    by afrezzauser Apr 3, 2014 7:39 AM
    dtrouble1003 dtrouble1003 Apr 3, 2014 9:03 AM Flag

    Hey Afrezzauser great job at the ADCOM. I have a real world question for you that was posed to me by my GF who is typeI. Is it possible to use Afrezza as a supplemental therapy to be used only in the morning for rapid reduction of morning highs (common problem) when she is currently using a pump with an RAA?

    This is an intriguing question, because if you can this alone is a huge beneficial use for Afrezza and will save diabetics thousands of hours in out of range highs over a lifetime. She also made the great point that supplemental use like this will open the door to further use by diabetics as it will familiarize them with the product and build confidence for further use.

    Anyway just curious about what you know about that? Thanks.

  • I know you will think I am crazy but the biotech sector rallied hard yesterday MNKD was -1% vs BIB and +3% vs IBB.

    Today we are +9% vs BIB and +3.47% vs IBB.

    All things considered this was actually a very strong day for MNKD........ buyers bought on weakness in the sector. That's a good sign.

  • Reply to

    Regarding the missing data....

    by factspls88 Mar 29, 2014 12:17 PM
    dtrouble1003 dtrouble1003 Mar 29, 2014 12:33 PM Flag

    100%. Drop outs are expected in any clinical trial. Various statistical methods are employed to deal with these fop outs. As I indicated in my other post FDA docs indicated all stats methods but one indicated noninferior outcome.

  • Insiders + institutional holdings = 65% of total shares
    Shorts = 12.75% total shares

    institutional holdings = 34% of the float
    Shorts= 27% of the float

    Due to the unusual huge inside ownership of shares, (almost unheard of levels), the short position is actually much more unsubstantial than we think. Long positions far outweigh the short interest.

  • The short thesis is really really weak. If that is all they are going on I will stick with my long position.

  • dtrouble1003 by dtrouble1003 Apr 2, 2014 9:17 PM Flag

    I'm not going to be shaken. I believe we are going to have a buyout immediately following PDUFA.

    Al was upstairs in the penthouse with Greenhill and sanofi working out the details based on type I and type II approval label alternatives.

    Final buyout 12billion to sanofi!!!

    Great to see some familiar names tonight! :)

  • Is the result of the jan 5.00 options finally being behind us and we are poised for a run? Though 47 million short is nothing to laugh at we also had 47 million short in April-August of last year, a period of substantial price appreciation. Perhaps others like myself took the proceeds of their 2.00 January calls and went longer on Friday? Time will tell who is correct! Good luck to all longs!

  • 1. Will the results of these trials be enough to satisfy the FDA based on their most recent Complete Response Letter?
    The recently completed Affinity trials were designed specifically to address the issues raised by the FDA in their complete response letters. In designing the Affinity trials we had multiple meetings with the agency to get their input and clarification on the protocols and endpoints of the trials. Based on those interactions and the trial results we believe that these studies have indeed met their primary endpoints and that the results will support approval of the product. However, we cannot at this time provide absolute assurance regarding the outcome of the FDA review and whether the agency will agree that the forthcoming NDA submission will be adequate for approval. There can never be certainty that the FDA would not still request that we conduct additional clinical studies. Although it is not relevant for purposes of predicting FDA action, Deerfield evaluated the two Affinity trials, including through an independent regulatory consultant with access to all the key data, and determined that the results met the primary efficacy endpoints and did not show any adverse safety issue that would reasonably be expected to prevent approval of AFREZZA®. Such validation was required for Deerfield to provide the second $40 million tranche of the $160 million financing.

  • dtrouble1003 by dtrouble1003 Jan 28, 2014 11:26 AM Flag

    Once market dominance is established by 2018 for prandial insulin, mnkd will complete studies which deliver a cocktail of both ultra-fast acting insulin and long acting insulin glargine offering for the first time a completely injection free option for diabetics around the world.

    This will succeed in spite of competition from oral insulin's for the long acting space, because Afrezza is 60% bioavailible while orals are 5-7% bioavalible. It will be an exciting future for MNKD.

  • FACTS:
    1) Afrezza is the fastest acting insulin in the world today.
    2) Afrezza's PK/PD properties are far superior to anything on the market today.
    3) In clinical trials Afrezza showed statistically significant benefit in Hypo events vs Novalog
    4) Afrezza met primary endpoints in two PIII clinical trials designed and coordination with the FDA in a SPA
    5) Afrezza has been shown to be safe and effective in over 6000 trial participants, showing no clinically significant impact on lung function or lung cancer risk.
    6) MNKD has a tentative ADCOM meeting scheduled for April 1 and a PDUFA date of April 15.

    Fiction:
    1) Afrezza is just like Exubera and will suffer the same poor sales as Exubera. (they are jumping to sales already)
    2) Afrezza causes lung cancer ( statistically in diabetic populations trial participants actually had fewer incidents of lung cancer compared to untreated patients)
    3) ADCOM is a terrible sign for the possible approval of Afrezza (do we need to even list all the examples of successful marketed NDA currently on the market that had an ADCOM?)
    4) FDA is concerned about lung function (where how when did they ever say that?)
    5) MNKD will never be able to find a partner (pure speculation)
    6) Mnkd has reached primary endpoints before while following fda protocols and was rejected, so surely it will be rejected again. (where do we begin?)
    7) Study 102 SPA from which studies 171 and 175 where designed to bridge safety data (dreamboat vs medtone) is not valid and will not be considered for MNKD's latest submission. (That's fantastic news, because if they are not even considering the SPA 102 data then they have already have deemed Afrezza safe and effective)

    I wonder who is suffering from group think? Seems to me Longs have a much stronger position. Please feel free to add and subtract MNKD Longs.
    In my mind the only risk is corruption by the FDA, but that isn't any better based in fact than any other short thesis

SNTA
3.97-0.07(-1.73%)Apr 17 4:00 PMEDT

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