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Sam Quirke

 
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  • The IBB Likely To Move Higher Along With These Biotechs With Catalysts Upcoming [View article]
    Scott, how would you compare the SPDR Biotech ETF 'XBI' against the 'IBB'. XBI is evenly weighted across all its components
    Jun 4 05:00 AM | Likes Like |Link to Comment
  • Why I'm A Bear [View article]
    How are you bulls feeling now? Didn't take you too long to run for the hills!
    Apr 11 02:39 PM | Likes Like |Link to Comment
  • Why I'm A Bear [View article]
    Indeed there have, but on average, bull markets don't last longer than 4 years and on average there is downward momentum during the mid term. This article essentially concerns the factors that exist today, and how they will drive this bull market back to the mean.

    Can you offer some constructive points to the debate on why you don't think they will?
    Mar 31 08:09 AM | 2 Likes Like |Link to Comment
  • Why Biodel Will Have Positive Phase II Results [View article]
    ''I'm impressed with your post-hoc trading: maybe BIOD should hire you to analyze its data?''

    Lol, I'd be pissed off as well if a recent graduate proved me wrong.
    Sep 13 02:45 PM | Likes Like |Link to Comment
  • Why Biodel Will Have Positive Phase II Results [View article]
    Good to hear you're all keeping well fellas. As Red Acre correctly pointed out, I have indeed taken up a new job that has me pretty busy - haven't traded since I closed my BIOD position for a 50% profit during that crazy volatility we saw at the start of August. Started the job the following week so wasn't able to play the results.

    With regards to BIOD's results; they met the primary endpoint-which I predicted and you ChasingTheAlpha and you Bio.Bobby did not. The injection site pain really surprised me and signals the end for BIOD-123 I believe, I thought after P1 trials, they had it sorted. No one is going to bother with an insulin that hurts to take, when there are similar ones that don't hurt.

    I expected a sell-off either way, unless we saw significant superiority rather than 'just' non-inferiority which was BIOD's goal, it was always going to have a stereotypical post-results run down as investors moved onto the next catalyst play.

    I've been out of the trading loop for a while and will continue to be so you may be waiting a while for my next article. In the meantime I hope you all get rich.

    PS. @chasingthealpha - you can call me 'all knowledgeable' when I'm tricking people into paying me to hear my random thoughts and musings. But save the spoilt child spiel until then.
    Sep 13 02:07 AM | Likes Like |Link to Comment
  • Why Biodel Will Have Positive Phase II Results [View article]
    http://bit.ly/14MiNgV

    Don't be afraid to Google things yourself, or Heaven forbid click on the link I provide in the article
    Aug 2 10:36 AM | Likes Like |Link to Comment
  • Why Biodel Will Have Positive Phase II Results [View article]
    The company said with the release of the Phase I results that:

    '' The objective of the trial was to identify an RHI-based formulation with pharmacokinetic and pharmacodynamic profiles similar to the Company's previous Linjeta™ formulation used in Phase 3 clinical trials, but with improved injection site toleration characteristics.''

    ie. Make a Linjeta without the injection site tolerability issues. Their objective appears to have been achieved.

    Their CMO then said:

    ''"Biodel's previous Linjeta formulation demonstrated a desirable ultra-rapid absorption profile, but had challenges with respect to local injection site toleration. The goal of our subsequent formulation development has been to maintain the ultra-rapid absorption profile of Linjeta™, while improving injection site toleration. These recent data suggest that our latest formulations have achieved this goal, and we feel that further clinical development is warranted."

    ie. We want to make Linjeta again, but without the injection site issues.

    Given Linjeta got so close, my point is that the Phase I data of BIOD-123 which we have coupled with the company's comments, suggests that it is everything Linjeta was and more. And as a result BIOD-123 will have positive Phase II data.
    Aug 2 09:20 AM | 1 Like Like |Link to Comment
  • Why Biodel Will Have Positive Phase II Results [View article]
    'Plus more' - read what I said - no injection site intolerability as shown in Phase I.

    I'm making what I think is a reasonable assumption/informed guess given what we know, that because Linjeta had fewer non-severe hyperglycemic events than RHI, BIOD-123 will have fewer than Humalog in Phase II. With regards to severe events, it'd be taking too big a step to go as far as to say that it'll have fewer of them as well.

    ''The Australian PK data suggests that 123 will be non-inferior to Humalog in A1c control, but that it will fail to show a benefit in hyperglycemic events.'' - why do you think it suggests BIOD-123 will fail in the hyperglycemic deptartment?
    Aug 2 08:41 AM | Likes Like |Link to Comment
  • Why Biodel Will Have Positive Phase II Results [View article]
    I think non-inferiority has already been established, not withstanding we're only at the Phase II trial stage.

    Positive for me, would be meeting primary endpoint of HbA1c control with postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes versus Humalog.

    Linjeta proved non-inferiority of HbA1c change when compared to RHI in its Phase III. It's my personal view, that BIOD-123 is everything Linjeta was plus more - injection site tolerability for starters.

    You know as well as I do, no one can ever be 100% certain which way a trial/PDUFA etc will go, especially if it's only Phase II. But given the information we have, given how close Linjeta came in 2010 and given that BIOD-123 is in my opinion, an improved version of it that seems to have taken care of the known problems, I think we're in for positive results.

    What's your own take?
    Aug 2 04:55 AM | 1 Like Like |Link to Comment
  • Why Biodel Will Have Positive Phase II Results [View article]
    He's make fair points with regards to the risk that exists, but there's going to be risk in every trade you're going to make. I'd be listening to the big dogs ie. Stock Matusow, Red Acre, BioRunUp not to mention Baker Bro's who are all predicting positive results.

    I've yet to see a coherent bear case for negative BIOD results, even bio.bobby can't give one. And with less that 3% of the float short going into this huge catalyst, neither can anyone else apparently.
    Jul 31 01:57 AM | Likes Like |Link to Comment
  • Why Biodel Will Have Positive Phase II Results [View article]
    Good and fair points that are hard to argue with. As with all stocks in particular biotechs, there's a huge amount of risk with catalysts like these. It'll be interesting to see what happens, either way, good luck with your trade whichever way you decide to go.
    Jul 30 04:30 PM | 1 Like Like |Link to Comment
  • Why Biodel Will Have Positive Phase II Results [View article]
    When you say 'chemically' what do you mean? Efficaciously or what?

    In its Phase I trail, BIOD-123 proved non-inferiority to Humalog (a marketed rapid acting insulin). It also demonstrated quicker absorption rates into the bloodstream. It was tolerated well. Are you trying to say that it doesn't work?

    As far as I can see, the main reasons Linjeta wasn't approved by FDA was due to intolerability and the mess ups with the India center samples. BIOD-123 has taken care of both these factors. I don't know if anyone but the mgmt will know what the FDA said when they met in the months after the CRL.

    With regards to the 'BIOD-105/107 failed therefore BIOD-123 must fail' argument, going by the company's PR on the Pump Study results of BIOD-105/107, efficacy was established but ''the two Biodel formulations did not meet the company's target product profile and, therefore, will not be advanced into Phase 2 clinical testing''.

    Maybe BIOD-123 has and is meeting the company's target product profile and maybe that's why it will succeed where BIOD-105/107 failed?

    Pump Study PR - http://bit.ly/1bOzdwD
    Jul 30 03:37 PM | 1 Like Like |Link to Comment
  • Why Biodel Will Have Positive Phase II Results [View article]
    I neither have the time nor the interest to search for public information that you yourself can find with your own effort. As a biotech catalyst investor, my interest, money and this article are focused primarily on the next two months for BIOD. Are you a BIOD bear? If so, what's your thesis given I've outlined my bull thesis?
    Jul 30 11:22 AM | Likes Like |Link to Comment
  • Why Biodel Will Have Positive Phase II Results [View article]
    ''Based upon the complete response letter and subsequent feedback that the FDA provided to us at a meeting in January 2011, we decided to study newer RHI-based formulations in earlier stage clinical trials. After reviewing the results of a Phase 1 clinical trial of two newer formulations, BIOD-105 and BIOD-107, we determined that the overall pharmacokinetic and pharmacodynamic profiles of these formulations did not demonstrate our target product profile. We subsequently conducted a Phase 1 clinical trial of two additional formulations, BIOD-123 and BIOD-125'' - short of ringing up the management, I think this is the best the public is going to come up with in terms of why they decided to revamp Linjecta. What are your own thoughts, short of bashing?
    Jul 30 11:03 AM | 1 Like Like |Link to Comment
  • Why Biodel Will Have Positive Phase II Results [View article]
    What do BIOD-105/107 have to do with BIOD-123? All one needs to know is that after the CRL mgmt went about selecting a new ultra rapid insulin and out of all the potential ones, BIOD-123 was most promising.

    How can you say Viaject wasn't viable when the only problem with it was injection site tolerability and those Indian center anomalies? It got to Phase III and NDA filing with no problems. If it wasn't 'viable' do you think it would have gotten past Phase I/II? The efficacy of BIOD's insulin candidates is beyond question
    Jul 30 10:42 AM | 1 Like Like |Link to Comment
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