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whippersnapper65 345 posts  |  Last Activity: 10 hours ago Member since: Jun 20, 2009
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  • Reply to

    MAY 2015 - Final Phase 3 results for Rindo

    by k.baker60 Jan 20, 2015 11:45 AM
    whippersnapper65 whippersnapper65 Jan 20, 2015 11:51 AM Flag

    You're wrong: the phase 3 trial, which is called ACT-IV, might not even have reached the interim analysis triggered by 50% of events/deaths by May. Management has projected that that threshold should be reached by mid-2015. Only after that interim has been reached will management be able to provide updated guidance about when the trial will be expected to conclude.

    Of course, if the data are superb and statistically significant then ACT-IV could be stopped early for efficacy at the first interim analysis. The superb results from ReACT and the delay in reaching 50% of deaths both lend support to the hypothesis that ACT-IV patients who are being treated with Rindo are doing well and living longer than originally expected.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 20, 2015 10:26 AM Flag

    They had to short intensely to avoid the share price running away from them. It almost got away from them when only about 50k shares took it from $21 to $21.48 in a heartbeat. Since then it's been walked and held down firmly.

    Sentiment: Strong Buy

  • Reply to

    Supply Wiped Out!

    by sr420steve Jan 16, 2015 9:30 PM
    whippersnapper65 whippersnapper65 Jan 18, 2015 1:26 PM Flag

    It wasn't. Options expired on Saturday.

  • Reply to

    What in store for next week?

    by grey3840 Jan 17, 2015 11:17 AM
    whippersnapper65 whippersnapper65 Jan 17, 2015 8:28 PM Flag

    Yes, and I found that very curious

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 17, 2015 4:25 PM Flag

    That would make sense because the commercial manufacturing process has to meet FDA guidelines just as it does for manufacturing drugs for clinical trials. It might have to do with scaling from clinical trials production (small quantities) to commercial production (large quantities). The FDA wants assurance that commercial production meets the same standards and quality as was present during production for clinical trials.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 17, 2015 1:23 PM Flag

    A chemical, manufacturing and control (CMC) section is a component of a submission for regulatory approval. It is not merely a pre-clinical consideration, as you state. It directly concerns applications for approval of new treatments. Refer to the following excerpt from a recent news story about an unrelated company and treatment for evidence of the importance of CMC in filing regulatory submissions.

    Also in the story below, note how quickly a treatment can be made available for commercial sale following approval. Rintega could be available for commercial sale this year.

    ---

    IPXL shares jumped 11.7% and attained a 52-week high on the FDA approval of Rytary, an extended-release oral capsule formulation of carbidopa-levodopa. The FDA has approved Rytary for the treatment of patients suffering from Parkinson's disease and post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication.

    We note that Rytary's approval path has not exactly been smooth with the company receiving a complete response letter for the drug in Jan 2013. The new drug application (NDA) was resubmitted by Impax in Apr 2014. However, the initial FDA action date of Oct 2014 was pushed out to Jan 2015 due to an amendment in the chemical, manufacturing and control (CMC) section of the resubmitted NDA.

    Rytary will be available for commercial distribution in Feb 2015 and Impax is currently seeking EU approval for the drug.

    Sentiment: Strong Buy

  • Read it and weep over the weekend, shorts: Celldex is preparing for regulatory submissions.

    Manager/Sr. Manager, Regulatory Affairs CMC & Operations (Needham, MA)

    Overview:

    Celldex is looking for a candidate to manage regulatory CMC aspects of Celldex's therapeutic development programs, in collaboration with regulatory product leaders. Responsibility includes authoring and reviewing CMC sections in regulatory submissions. This person will also manage regulatory submissions and applications for clinical trials, agency meetings, annual reports, and maintenance required for INDs and CTAs.

    Sentiment: Strong Buy

  • The trial is newly listed under a search of "Celldex". Yesterday there were seven open trials; today there are eight. This trial is the newly listed one:

    DEC-205/NY-ESO-1 Fusion Protein CDX-1401and Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

    The trial sponsor is Roswell Park Cancer Institute. Yesterday's change added Celldex Therapeutics as a sponsor of the study even though the study has been ongoing since July 2013.

    Perhaps somebody wants Celldex to get proper exposure for this study and for CDX-1401, which is why Celldex was just acknowledged as a sponsor.

    Sentiment: Strong Buy

  • Reply to

    Harry Boxer's Charts of the Day

    by justasklee Jan 16, 2015 9:41 AM
    whippersnapper65 whippersnapper65 Jan 16, 2015 4:28 PM Flag

    I suspect CLDX will be featured on Harry Boxer's Charts of the Day again this evening with comments about how the large price move and tremendous volume confirm the breakout and set expectations for a short-term goal in the mid $20s and potential to continue rallying strongly.

    Sentiment: Strong Buy

  • Reply to

    question about price

    by irenecarol Jan 16, 2015 2:58 PM
    whippersnapper65 whippersnapper65 Jan 16, 2015 3:06 PM Flag

    Shut up. Do your own research. Go away. You are on ignore. I couldn't care less what you do or don't do.

  • whippersnapper65 whippersnapper65 Jan 16, 2015 12:14 PM Flag

    I agree with you: the case for early approval of Rintega in both the relapsed setting and in newly diagnosed GBM is about as solid as one can imagine it being. Perhaps that has something to do with the rally in the share price this morning. The market should be coming to terms with Celldex becoming a profitable commercial biotechnology company, perhaps this year.

    Sentiment: Strong Buy

  • Reply to

    Well played

    by medtodamoon Jan 15, 2015 6:43 PM
    whippersnapper65 whippersnapper65 Jan 15, 2015 6:59 PM Flag

    Institutions are relying on people like you to be margined or stopped out so they can increase their ownership percentages. Why do you think the price has swung so volatilely intraday so frequently? The institutions want to trick or force or scare longs into selling.

    Sentiment: Strong Buy

  • Reply to

    18 GOOD SUPPORT - FOLLOW MY LEAD

    by vivaespana11 Jan 13, 2015 3:36 PM
    whippersnapper65 whippersnapper65 Jan 15, 2015 11:36 AM Flag

    vivasheethead is a narcissist. Put him on ignore. He's only looking for attention. Don't even give his posts a red thumb. Just ignore him. The guy posts several times in response to his own posts when nobody responds because he's trying to provoke a response. I sized him up almost immediately and he's been on ignore even since. I laugh when I see a string of seven or so vivasheethead posts that have been whited out because he's on my ignore list. The guy is an attention-seeking loser.

  • Reply to

    they will sell at 18.50

    by tackenguyen1983 Jan 14, 2015 12:52 PM
    whippersnapper65 whippersnapper65 Jan 14, 2015 1:32 PM Flag

    You still read that guy's messages? Ignore and move on.

  • whippersnapper65 whippersnapper65 Jan 13, 2015 10:14 PM Flag

    Why don't you enlarge that time horizon? What's special about the past two months? Seems arbitrary. Why not take a twelve-month perspective? Then there isn't as much to like. You can arbitrarily select any time period that supports your sentiment and say, "Look, see! I told you!"

    CLDX ought to be trading in the $30s right now. Regardless of the price performance over the past two months or for the next six months, until it's in the $30s longs can't point to the share price itself as a reason to be excited about CLDX.

    Sentiment: Strong Buy

  • Reply to

    What the heck just happened ?

    by obnox2 Jan 13, 2015 2:15 PM
    whippersnapper65 whippersnapper65 Jan 13, 2015 3:34 PM Flag

    We've all already bought our shares. It's long past time for the share price to surpass $24.50, which was considered by institutions to be a deal thirteen months ago. A negative 25% return over thirteen months isn't a bargain and it definitely sucks.

    Those of us who bought below $4 are, of course, sitting pretty. However, that doesn't mean that a floundering share price in the aftermath of the best news the company has ever released is alright with us.

    Sentiment: Strong Buy

  • Reply to

    BMY and CLDX start 1127 Trial-BMY to Announce?

    by maximus06906 Jan 12, 2015 2:01 PM
    whippersnapper65 whippersnapper65 Jan 12, 2015 9:49 PM Flag

    That was a PR about the collaboration agreement. I'm referring to a PR about opening the trial, whose protocol has now been finalized, to patient recruitment. They are not the same thing, and the commencement of the trial ought to be newsworthy.

    Sentiment: Strong Buy

  • Reply to

    BMY and CLDX start 1127 Trial-BMY to Announce?

    by maximus06906 Jan 12, 2015 2:01 PM
    whippersnapper65 whippersnapper65 Jan 12, 2015 6:17 PM Flag

    I hope that the two companies have coordinated their public announcements such that in the morning tomorrow before the market opens both Celldex and BMS will issue a joint press release announcing the opening of the varli/nivo combination trials to recruitment. The press releases should further mention the recent FDA approvals granted to nivo and have a statement or two about the exciting possible synergistic effects of combining varli and nivo, whose biological mechanism of action has been observed in pre-clinical studies.

    Then BMS presents at noon and reiterates the points in the press releases.

    That would produce the most bang for the buck in exposure and should result in a nice bump in the share price.

    Sentiment: Strong Buy

  • Reply to

    BMY and CLDX start 1127 trial

    by lennox64 Jan 12, 2015 1:03 PM
    whippersnapper65 whippersnapper65 Jan 12, 2015 1:12 PM Flag

    Great news. That must have been posted today because it wasn't there yesterday.

    Sentiment: Strong Buy

  • Reply to

    VARLI's Value Went Up Today - AS Did CLDX

    by goforitmedx Jan 12, 2015 11:47 AM
    whippersnapper65 whippersnapper65 Jan 12, 2015 12:33 PM Flag

    CLDX should already be trading in the $30s. It would be nice for the market to come to that realization soon.

    Sentiment: Strong Buy

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