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  • Apricus Biosciences: A Transformative Year Ahead [View article]
    Thanks. Stock price seems to be responding accordingly...

    Good luck this week,
    CF
    Apr 8 05:16 PM | Likes Like |Link to Comment
  • The Week Ahead Could Be Pivotal For These Small-Cap Companies' Stocks [View article]
    Not really. It depends on how many patients overall they will need to enroll. I'll dig around some... Thanks for the kind words...

    CF

    " With initial enrollment of 163 patients targeted, the company will then perform a sample size re-estimation to determine what number of patients ultimately enrolled would be necessary to have statistically significant results at the trial's conclusion, with a range of 326-652 patients expected. Updates on this final enrollment size will indicate how much longer the trial may take and give an indication about how much more money PLC would require for trial completion."
    Apr 8 05:15 PM | Likes Like |Link to Comment
  • Small Pharma Watch List: Week Of April 8, 2013 [View article]
    You're correct on the cash value at $33 million. The $298 million is actually "Cash, cash equivalents and available-for-sale
    securities"

    Thanks
    Apr 8 05:13 PM | Likes Like |Link to Comment
  • Small Pharma Watch List: Week Of April 8, 2013 [View article]
    The "4 & 4.25" are resistance levels (split adjusted), not the values at the time of the split. The 2 prices are the two resistance levels.... split adjusted...
    Apr 8 05:10 PM | Likes Like |Link to Comment
  • Apricus Biosciences: A Transformative Year Ahead [View article]
    Thanks for the solid comments Eicoman. I think there is a key point to remember. Apricus had already paid for the Totect and NitroMist licenses and was ready to start generating revenue off them. To totally abandon those and focus on its sexual dysfunction product line says much about their confidence in profits and regulatory pathways forward for Femprox and Vitaros.

    Best of luck....
    Apr 3 08:49 PM | Likes Like |Link to Comment
  • The Week Ahead Could Be Pivotal For These Small-Cap Companies' Stocks [View article]
    These are all gambles.. Just as with poker, you don't always have to have the best hand to win... :)
    Apr 2 09:01 PM | Likes Like |Link to Comment
  • The Week Ahead Could Be Pivotal For These Small-Cap Companies' Stocks [View article]
    Sure thing sir. Great to see you in DARA. I feel like I'm in good company...
    Apr 2 02:07 PM | Likes Like |Link to Comment
  • Trovagene's Novel Diagnostics Platform To Garner Attention In 2013 [View article]
    I agree that the technology is not as straightforward as it might seem on the outside. However, if TROV has multiple patents covering certain aspects of the diagnostics, it stands to reason that could be part of the reason HDVY, NEO and Quest haven't successfully developed a urine test..... many of TROV's patents are limiting what others can do... nonetheless, they already have a launch to their credit this week for HPV, something the aforementioned companies haven't managed to do yet for urine samples. If development-stage TROV can pull it off for one indication, it could likely do it for others. We will soon see as validations and launches move forward in 2013.

    Thanks and best of luck to you.
    Mar 28 08:37 PM | Likes Like |Link to Comment
  • Imminent Catalysts Should Keep Investor Interest Alive For These Pharmaceuticals - Part II [View article]
    I'm not sure. I think it can be day-traded for quick flips today and perhaps Monday with current volatility. I hate giving a company too many opportunities to get through CRL's, especially given the company's diluted share structure. The company will be spending cash in the interim and competitor products will be moving closer to approval. Perhaps double up and hope for a gradual trend up with a tight stop limit in the event it starts bleeding down?

    Thoughts??
    Mar 28 11:59 AM | Likes Like |Link to Comment
  • Pivotal Phase III Trial Data Ahead For 3 Development-Stage Small Pharma Companies [View article]
    Hi and great to see you here. Welcome to Seeking Alpha! Stay in touch and find us some great investment ideas! :)

    CF
    Mar 27 01:12 PM | Likes Like |Link to Comment
  • Affymax Will Rise Again [View article]
    Nice, informative article WalkTheTalk. You've done a great deal of work on this piece. There are so many positive ways for this to play out with solid upside potential ranging from labeling restrictions all the way up to no restrictions whatsoever if the fault is found to be with an adjuvant or manufacturing issue (bad raw material, etc).

    Yes, the downside does exist and I will keep that in mind. I have stop limits in place but do realize they wouldn't be of any help in a "gap down" type of scenario.

    Thanks again for the work and I appreciate the insight. As investors we all have to weigh the risks and ascertain what is truth, partial truth or fiction. You add more information to our arsenal by which we can hopefully make our decisions. Please keep up the good work!
    CF
    Mar 20 10:56 PM | 2 Likes Like |Link to Comment
  • Small Pharmas With Imminent Catalysts For March 2013 [View article]
    Agreed Walk, that's exactly why I noted it as speculative. I main mentioned it because that type of companion diagnostic could help salvage the drug over the mid to longer term if screening could free up a patient set. Thanks and have a great week ahead. CF

    "Although Arrayit could provide a possible means to evaluate the patients experiencing adverse events with regard to OMONTYS and a means to screen future patients, the company should only be considered as a speculative possibility unless more information can be presented by the company."
    Mar 13 12:04 AM | Likes Like |Link to Comment
  • Athersys' MultiStem Platform Tempts Big Pharma And Investors [View article]
    Noted. Thanks.

    It appears that ATHX support is holding very well, closing today at $1.57. Now we need to see how it holds up on a red market day.
    Mar 5 11:49 PM | Likes Like |Link to Comment
  • Speculation On The Cause Of The OMONTYS Recall [View article]
    Interesting note on removal of excess PEG, at least in one application:
    http://1.usa.gov/YbNN6T

    F(ab')2 pegylation

    After preparation, the F(ab')2 were dialyzed against borate buffer 0.02 M pH 9 before conjugation to PEG using a 3-fold molar excess of PEG (15 nmoles) added to 500 µg (500 µl of a 1 mg/ml solution) of dialyzed F(ab')2 (5 nmoles). After 30 min at room temperature with gentle agitation, F(ab')2 were purified by cation exchange chromatography to remove unreacted PEG and to separate the different F(ab')2 species (nonpegylated, monopegylated and multipegylated F(ab')2). A MacroCap SP column (GE Healthcare) (10.5×1 cm) was used with an AKTÄ system (GE Healthcare) and equilibrated with buffer A (0.02 M acetate buffer pH 5) at a flow rate of 1 ml/min. The reaction mixture was filtered through a 0.2 µm filter and loaded onto the column. After washing the column with 17 ml of buffer A at 1 ml/min, the pegylated F(ab')2 was eluted using successive gradient steps of 12 ml each at 2, 3, 4, 5 and 25% of buffer B (0.02 M acetate buffer pH 5+1 M NaCl) at 1 ml/min. The column was regenerated with 17 ml of buffer B at 1 ml/min. During the chromatography, fractions of 1 ml were collected and the absorbance was monitored at 280 nm. Fractions corresponding to each peak were pooled and analyzed by SDS-PAGE.

    Observations: a 3-fold molar excess of PEG was utilized in that particular scenario, noting that it is possible the OMONTYS manufacturing may also incorporate excess levels of PEG (nothing alarming about that as long as it's removed before the final product goes out the door). Cation-exchange chromatography was used in the above example (plausible on a larger scale with larger production-scale batches but with much much bigger cation-exchange columns).

    Possibilities:
    Not enough PEG was utilized (for several batches/lots, it could be because lower purity PEG was utilized, but with the lower purity not compensated for by using more, the pegylation reaction would not have yielded 100% desired final product but would rather have some lower molecular weight peptidic ESA unreacted, which could trigger anaphylactic shock due to immunogenicity.

    Too much PEG was utilized, which in itself can trigger hypersensitivity also. If this is sufficiently removed, no problems. However, if the cation exchange or other means of excess PEG removal was inadequate due to processing issues or due to higher levels of PEG than the system can adequately clean up, the PEG could carry into the finished product in PEG form, or produce other undesirable products depending on what else is in the solution/mixture.
    Mar 5 11:36 PM | 1 Like Like |Link to Comment
  • Speculation On The Cause Of The OMONTYS Recall [View article]
    Known as Hematide at the time of the clinicals, OMONTYS information at 2008 ASCO:

    "With the use of Nektar's advanced PEGylation technology, the properties of therapeutic agents, such as Hematide(TM), can be enhanced by increasing drug circulation time in the bloodstream, decreasing immunogenicity, and reducing dosing frequency. Nektar proprietary technology uses advanced conjugation chemistry and techniques to attach polyethylene glycol polymers to therapeutic agents."

    So, if PEG was of lower purity than actually stated (for example 90% instead of 98%), than the pegylation reaction wouldn't be efficient and yield 100% peginesatide. If that is the case, then let's say that about 5% of the peptidic ESA is still in the lower molecular weight form. If that is the case, there may be some induced immunogenicity which could possibly trigger the anaphylactic shock and other adverse events? See the following link about immunogenicity and anaphylactic shock: http://bit.ly/YMv8i2

    In other words, excess PEG could be the culprit as could a shortage... Too much PEG left over in the final product could cause hypersensitivity while not enough could leave enough to leave lower molecular weight peptidic ESA unreacted which could induce immunogenicity and also trigger the AE's.

    This is just conjecture and should not yet be construed as a "smoking gun".
    Mar 5 11:00 PM | Likes Like |Link to Comment
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