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Trius Therapeutics, Inc. (TSRX) Message Board

markak1515 34 posts  |  Last Activity: Jul 9, 2014 11:08 AM Member since: Apr 15, 2005
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  • Reply to

    Some body knows something here

    by holycowitsterrific May 8, 2014 11:56 AM
    markak1515 markak1515 May 8, 2014 12:05 PM Flag

    No one knows anything. 15-20k shares means nothing. Any joe schmo can dump 20k shares...less than $10k

  • because the stock has been cut in half since Jan. Hopefully it's just an illusion and when he gets on the conference call Friday it will be whole again.

  • Reply to

    Friggin FDA

    by markak1515 May 2, 2014 12:04 AM
    markak1515 markak1515 May 2, 2014 9:39 AM Flag

    I'm not trying to find my way to the FDA's heart. I'm doing an honest assessment and trying to figure out why the CE Mark takes 6 months and the FDA process for the same product takes 4+ years. Is it because the FDA cares more about the safety of American's than EU regulators care about Europeans? I don't think so. FDA is way too fickle and they get away with it. They can change their mind whenever they want with no accountability.

  • Reply to

    Friggin FDA

    by markak1515 May 2, 2014 12:04 AM
    markak1515 markak1515 May 2, 2014 10:13 AM Flag

    I think the FDA is doing okay when it comes to NDA/BLAs. I just find the PMA process in particular incredibly painful and controlled by whimsy and politics instead of science.

    And my experience is contrary to what you are saying about CE Mark. Take CorMedix for example, CE mark was obtained July of last year, product was sold in December of the same year. Sure there is some additional paperwork for certain countries but you can at least be assured once you have the CE Mark, it's just paperwork. You're not going to get the CE Mark and then France is going to say "we want to see an additional 500 patient clinical trial."

  • markak1515 by markak1515 May 5, 2014 9:59 AM Flag

    LuViva is the best screening tool out there. If I'm GE or some other large device maker, why not buy GTHP, run the 10,000 patient pivotal trial required to get Luviva approved as a primary screening tool, and then you have a unique device which no one else has which will become the standard of care? Seems like an investment of maybe $200M would allow a large company like GE to establish themselves as the dominant force in screening for cervical cancer.

  • Reply to

    Just got wind of our earnings report

    by holycowitsterrific May 12, 2014 12:30 PM
    markak1515 markak1515 May 12, 2014 1:57 PM Flag

    I've had no issues getting information from them.

  • Reply to

    FDA Question?

    by edfiggy May 2, 2014 9:42 AM
    markak1515 markak1515 May 2, 2014 9:55 AM Flag

    I would say if it takes 180 days or more, it's not getting approved. If it's approved, I think it will be much less than 180.

  • Reply to

    This company is set up to do very well.

    by wizdom3 May 16, 2014 12:43 PM
    markak1515 markak1515 May 20, 2014 12:10 PM Flag

    added on the dip into the $1.30s this morning. Very little risk here and plenty of near-term catalysts. I think we will get news soon that will get the stock out of this funk.

  • It's been a long time since GTHP traded like it has the last 2 days. Maybe Cartright is working for GE and was hired to do DD from the inside, and now GE is going to acquire GTHP. Certainly seems like the perfect time for acquisition. The price is still cheap but regulatory risk has been mitigated significantly.

  • markak1515 by markak1515 Apr 28, 2014 3:46 PM Flag

    Every time I see news of the Roche PCR test in the media, GTHP drops. People don't get it. The PCR test gives a positivity rate of 2-10%. Plenty of those are false positives. This is where Luviva comes in, to confirm or reject the PCR test. Really....Luviva should be a primary screening tool but GTHP just doesn't have the resources to conduct the 10,000 patient pivotal trial that would be required to achieve that.

  • Reply to

    Very Quiet

    by beasley22000 May 6, 2014 7:18 AM
    markak1515 markak1515 May 6, 2014 4:05 PM Flag

    a month since last PR and the last few PRs were all about additions to the BOD. It's been 4 months since we had a PR that was meaningful on the business side. Hopefully these guys have been hard at work and soon news will start to flow.

  • Reply to

    Seanoise was right, I was wrong.

    by gmeabrk Apr 23, 2014 9:36 AM
    markak1515 markak1515 Apr 23, 2014 7:41 PM Flag

    sure it is. FDA grants meetings on this kind of timeline all the time. I know from first hand experience.

  • Reply to

    Switched Accounting Firms

    by garyjc2 May 18, 2014 6:15 PM
    markak1515 markak1515 May 21, 2014 4:29 PM Flag

    Not that concerned but that could be because my cost average is well under $1. If you asked me December 15th "how does $1.33 sound?" I would have been thrilled with that price. I feel horrible for the people who bought $3+ but am also confident we will get back to $3 and beyond IF these guys execute like they are saying they're going to do. It's not realistic to expect huge revs from a patient population of a few thousand in 1 country on the very first quarter. They need label expansion and they need distribution agreements in place.

  • Reply to

    Delisting

    by lost.believer Jun 10, 2014 11:07 AM
    markak1515 markak1515 Jun 10, 2014 2:26 PM Flag

    There is no real problem with delisting, it's tied to this derivative liability which will fluctuate with the stock price. They will eventually fix this issue but I guarantee you the company is not going to get delisted.

  • Reply to

    Calling people names

    by classshopper Jul 9, 2014 10:28 AM
    markak1515 markak1515 Jul 9, 2014 11:08 AM Flag

    FDA approvals in sight? Wow, you are delusional. Only thing in sight is phase 2 data in melanoma and breast cancer, both of which would require a large phase 3 study and overall survival data to even file for approval. GBM is their best shot but phase 1 has not even begun yet. Let's be realistic here, Ziopharm is at least 3-4 years from having a product approved and that's if all the data is perfect and they move lighting fast.

  • Reply to

    FDA Question?

    by edfiggy May 2, 2014 9:42 AM
    markak1515 markak1515 May 2, 2014 9:45 AM Flag

    Neither of you, the FDA will do whatever they please. Seriously though, I think it's likely to be some where in between. They're not going to walk out of the meeting and say "okay you're approved" but given that they've reviewed the application numerous times already, it's not going to take 180 days.

  • markak1515 by markak1515 May 14, 2014 9:29 AM Flag

    I'm optimistic. There was a bid at $0.545 in PM but it's gone now. Would be surprised if it jumped that much.

    Guess it's back to the waiting game. ~225 days max, hopefully less.

  • markak1515 by markak1515 May 13, 2014 3:04 PM Flag

    Does anyone know how OGEN plans on protecting mu1140? I was reading one of their recent filings and it looks like the original patents expire in 2017 which will be well before it's even approved. I'm wondering if they can file more specific patents on the new variants they are testing now. I sent this question to Dr. B and he delegated it to one of his associates, but so far no one has given me an answer.

    This is my only concern. If they can file new IP, then I like OGEN as a long-term hold. Antibiotic resistance is not going away anytime soon, so as more antibiotics start to fail, the value of OGEN will go up and up. They should easily be able to raise any funds required to completely clinical development and the regulatory pathways for approval of new antibiotics is getting easier and easier every day.

  • Reply to

    Switched Accounting Firms

    by garyjc2 May 18, 2014 6:15 PM
    markak1515 markak1515 May 21, 2014 12:30 PM Flag

    companies switch accounting firms all the time. Not concerned at all...

  • Reply to

    any reason why this is getting killed again today

    by spencerp69 Apr 16, 2014 10:31 AM
    markak1515 markak1515 Apr 16, 2014 4:49 PM Flag

    Agree, been buying here and there since $2.30. Added heavily today and yesterday at $1.55 and $1.65. News should start to flow in the next few months and new 52-week highs will be here before we know it.

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