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whippersnapper65 350 posts  |  Last Activity: 21 hours ago Member since: Jun 20, 2009
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  • Reply to

    A Republican Governor in Maryland???

    by raysfrom98 Nov 5, 2014 12:42 AM
    whippersnapper65 whippersnapper65 Nov 5, 2014 12:48 AM Flag

    A Republican governor in ILLINOIS too! The incumbent candidate BHO campaigned for lost in BHO's home state.

  • From the 3Q PR: "We look forward to presenting data from the rindo program in recurrent GBM at the SNO meeting this month and completing planning for a number of new studies across our pipeline, including the initiation of the combination varlilumab and nivolumab study," concluded Marucci."

    That sort of language in past PRs has been an indication that forthcoming data will be positive. Why would the company "look forward" to presenting poor data?

    There have been so many tells that ReACT data will be positive. A blind person could connect the dots because they are so prominent as to almost be like Braille. The question is, "How positive are the data?"

    I'm maintaining the ReACT data will be highly positive, for that is what makes most sense in my mind of Marucci's actions in hiring and preparing a marketing and sales force and in speaking so enthusiastically and with increasing confidence and optimism about Rindo commercialization for the past nine months. I'm hoping that the data will be good enough to support an application for early approval from the FDA.

    Here's another statement from the PR that stands out: "Target enrollment (n=700) in ACT IV, the Phase 3 registration study of newly diagnosed patients with GBM has been reached. Given the lack of treatment options for patients with GBM, previously screened patients who are positive for the EGFRvIII mutation will be allowed to enter the study before enrollment is formally completed later this year."

    Allowing unneeded screened patients who are EGFRviii+ to remain in the study is truly a compassionate and honorable decision, and I commend Marucci for that. It shows his concern for GBM patients who have almost no other treatment options, and if Rindo does work well then giving the patients Rindo is their best chance.

    The fact that these GBM patients have almost no other options is a factor that I believe will weigh heavily in an FDA decision to grant early approval for Rindo based on outstanding ReACT results.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Nov 5, 2014 12:17 AM Flag

    Temporal, there's another factor you're neglecting: cash burn and cash reserves. Rindo is the only treatment that now has a chance of being approved by 2017. But Celldex runs out of cash at the end of 2016. Your point that *merely* adequate data would be sufficient from a scientific standpoint is true. However, Celldex is a business, so there is a business standpoint as well.

    From the business standpoint, *merely* adequate data won't cut it because it won't be enough to assure Celldex of financial solvency by 2017. Stupendous data that would lead to early approval for Rindo would assure financial solvency for the company because it would generate a revenue stream that would offset the staggeringly high quarterly burn rate of nearly $30 million.

    With *merely* adequate data, there will probably be no commercialization of Rindo until late 2016 because of the delay in ACT IV's patient accrual. Even assuming ACT IV meets its primary endpoint and Rindo is approved, sales wouldn't begin until 2017. But Celldex would have run out of cash in 2016.

    What concerns investors like me is, looking two years down the road, what is the business plan for ensuring that the company can remain solvent through to commercialization? Will there be another secondary? At what share price? If it were offered today, it's likely the offering would be at $11 or so. Our investment would be further diluted. We don't want the financial or business side of the company to be a Sword of Damocles hanging over the company's neck.

    Marucci has been hiring and prepping a marketing and sales force. He'd better have a damn good reason for doing so in 2014 if commercialization isn't expected until 2017.

    Now I suspect Marucci has been prepping for early approval of Rindo in 2015 based on ReACT. I don't know, but that is what I think. That is what makes the most sense of Marucci's actions in my mind. That is why I expect ReACT to produce stellar data.

    If it underwhelms, AM has business explaining to do.

    Sentiment: Strong Buy

  • whippersnapper65 by whippersnapper65 Nov 4, 2014 11:54 PM Flag

    He's so petulant, narcissistic and power-drunk that I bet he'll go all imperialist president for the next two years, daring Congress to impeach him.

  • G&A Expenses: General and administrative (G&A) expenses were $5.0 million in the third quarter of 2014 and $14.4 million for the nine months ended September 30, 2014, compared to $3.6 million and $10.1 million for the comparable periods in 2013. The increase in G&A expenses was primarily attributable to higher personnel-related expenses and == rindopepimut and glembatumumab vedotin commercial planning costs in 2014.

    "rindopepimut... commercial planning costs."

    If Marucci doesn't expect and doesn't have evidence that Rindo will be commercialized in 2015, then he is wasting company money with commercial preparation in 2014.

    Marucci has spoken quite a lot about how prepared Celldex is going to be for Rindo commercialization: "we're going to hit the ground running." I hope so. I sincerely hope so. But those preparations will have been wastefully premature if ReACT turns out to have underwhelming data.

    I have said it many times since August, and some of the longs on this board are tired of hearing it, but it is the absolute truth. The ReACT data will be the most pivotal event for Celldex's future this year. Marucci knows the data. He has had some idea about the data's trend for at least the past nine months. He knows what cards he's holding, and he knows that he has not been at liberty to disclose what he knows to investors. Yet all this year Marucci has spoken in glowing terms about Rindo commercialization and assembled a sales force with many years of experience in oncology marketing. And all this year he has been spending company money like it won't run out.

    Marucci's optimistic words and lavish expenditures only make sense if Rindo commercialization is a virtual certainty based on highly positive ReACT data. If the data are inadequate to support early approval, you have to ask what Marucci has been thinking and why he has acted and spoken the way he has for nine months.

    November 14 is the day of reckoning. Marucci's credibility is seriously on the line.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Nov 4, 2014 8:35 PM Flag

    It's not waffling, nor is it being fickle, if there is a major new piece of evidence that ought to cause reconsideration.

    The redesign of METRIC is not a minor issue. It is a major change in direction, resulting in at least a one-year delay.

    If you can't see that the redesign of METRIC is a big deal, perhaps you are a child.

    Why didn't management have the balls to host a conference call explaining their decision and taking questions about it?

  • whippersnapper65 whippersnapper65 Nov 4, 2014 8:04 PM Flag

    I have the temperament for biotech. I don't have the patience for management that proves itself untrustworthy.

  • whippersnapper65 whippersnapper65 Nov 4, 2014 8:00 PM Flag

    In temporal's defense, CLDX did trade up after hours for a brief time. I saw it trade at $16.65 after hours.

  • whippersnapper65 whippersnapper65 Nov 4, 2014 7:46 PM Flag

    While that might be the case with ACT IV, management has stated that the delay in METRIC is because doctors complained that the enrollment criteria were too narrow, making it difficult to enroll patients. So now the METRIC protocol is being amended but Marucci assures us that he is cooperating with global regulatory agencies, including the EU, to ensure that the revised protocol will be sufficient for approval.

    ACT IV's delay in reaching the first interim look by the IDMC is likely because of patients surviving longer than expected, and that is good.

    METRIC's delay in reaching full enrollment will be due to management amending the trial protocol and a lackluster number of patients enrolling during the first year of the trial. That is neutral from a scientific standpoint, problematic from a business standpoint.

    Sentiment: Strong Buy

  • Reply to

    They Have Enough Cash

    by j20tower Nov 4, 2014 7:00 PM
    whippersnapper65 whippersnapper65 Nov 4, 2014 7:15 PM Flag

    They said in mid-January that they expected to complete enrollment in the CDX-1135 pilot study by the end of January. How did that turn out?

    Even if they do have enough cash to fund operations through 2016, that means at the end of 2016 they will have close to zero cash unless they raise cash. They can't wait until late 2016 to raise more cash because the share price would be slaughtered. If they don't produce a revenue stream by late 2015 from early Rindo approval then they will have to raise cash either via partnership or a secondary offering.

    If Marucci knows the ReACT data are sufficient to support early Rindo approval, all is well and good and all will be forgiven. We don't know what he knows, so we have to trust. Marucci can't know that the Varli phase 2 trials will go well. We hope they will, but you can't bank on that as a possibility for a future partnership.

    From a business perspective, unless Marucci knows he will have a revenue stream starting in late 2015 from early Rindo approval, then he is making some very risky and even dicey business decisions by spending so much money on development.

    If the company has no approved product one year from now and has only $100 million in the bank after spending $120 million over the next twelve months, the share price will still be below $20 because everyone will expect a secondary offering.

    It all hinges on ReACT.

    November 14 will be the day of reckoning.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Nov 4, 2014 7:08 PM Flag

    Ray, if Marucci doesn't have truly impressive ReACT results, results that leave no doubt in people's minds that Rindo will be commercialized in 2015, then what does he have for the next two years? Nothing but cash burn in the amount of $120 million per year. The secondary that was offered one year ago was predicated in large part on providing a financial runway to commercialization. If commercialization is pushed back to 2017 or 2018, there's no way that the company can operate under prior assumptions; it will have to raise more cash.

    And it will be time to doubt Marucci's ability to lead the company.

    They designed METRIC to provide the best chance for an accelerated path to approval so that the company could generate revenue that would fund continued operations and further development of Glemba in a larger trial. Now they want to expand Glemba into an enlarged population of TNBC patients at significant delay in reaching commercialization? Why didn't the brilliant managers do that in the first place if that was such a wise pursuit?

    Something is beginning to smell a lot like the odor of CDX-1135.

    Marucci has been ramping up the sales force for Rindo and talking highly optimistically about revenue prospects. If commercialization is still two years away, he's awfully premature in that.

    If ReACT doesn't provide convincing data to support early approval of Rindo, then CLDX becomes a hold at best, possibly a sell.

    I'm willing to give Marucci a little more time -- until November 14. After that, it depends on ReACT and the company's decision about how to proceed with Rindo commercialization in 2015.

    Sentiment: Strong Buy

  • Management is spending money like Democrats.

    $28 million per quarter losses cannot be sustained nor justified unless revenue from an approved product is near.

    Has management bitten off more than it can chew? Is management's ambition to grow the company writing checks that the company won't be able to pay in two years? Delays in both of the company's lead programs have now occurred.

    If ReACT doesn't stagger with impressively positive results, the top five or six holders -- whatever it takes to reach 51% -- ought to collude to sell the company.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Nov 4, 2014 5:05 PM Flag

    But whereas nine months ago cash to last through 2016 was deemed sufficient because Rindo and Glemba would (it is hoped) be approved in 2016, now Glemba is out of that picture. The only hope CLDX has for a revenue stream from a commercialized product by 2016 is Rindo. But with the delays in reaching full enrollment in Rindo (delayed by at least six months), if ACT IV has to wait until the full completion of the trial for approval then you're looking at a very late 2016 approval at the earliest, probably more likely a 2017 approval.

    If Rindo can get early approval, then the money problem is solved. As things stand now, CLDX and Marucci have a money problem whose clock will stop ticking at the end of 2016 unless more time is bought. There are three ways to buy more time: 1) early approval for Rindo, 2) cash infusion from a partnership, 3) raising capital through another secondary offering.

    If the ReACT data are not absolutely, mind-blowing positive, such to make a compelling case for early approval, then Marucci's judgment and credibility should be called into question. He has been making promises and painting an optimistic picture. Meanwhile, target dates have been pushed back in Rindo (first) and now for Glemba.

    If the ReACT data are not spectacularly positive, then I think CLDX will be dead money for at least a year.

    The ReACT data are that important.

    Marucci had better deliver.

    Sentiment: Strong Buy

  • Explanation in the 3Q press release.

    That will delay full enrollment of the trial until 2016.

    Unless Rindo gets early approval in 2015 or a partnership is signed in 2015, CLDX is going to need to raise capital again in 2H 2015 or 1H 2016.

    Marucci had better know what he's doing.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Nov 4, 2014 12:28 PM Flag

    There is a video online showing the voter's finger selecting the Republican candidate but the machine casting the vote for the Dem. Twice.

  • Third state this is happening in. Why are the votes always changed to Dems?

    Democrats are cheaters who routinely support and encourage and commit voter fraud.

  • whippersnapper65 whippersnapper65 Nov 4, 2014 12:24 PM Flag

    Democrats use government offices and flexible interpretations of legal "discretion" to advance themselves and their party, and to obstruct their opposition. They illegally use government office and power for purely political purposes.

  • whippersnapper65 whippersnapper65 Nov 4, 2014 12:22 PM Flag

    I believe the president knew about it because he ordered it or approved it when it was suggested by underlings. All those meetings in the Oval Office between the president and IRS officials, and we are to believe the president was in the dark?

  • Recruiting as of November 3.

    There will be a barrage of PRs this quarter about more Varli combination trials initiating.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Nov 4, 2014 12:02 PM Flag

    Tea Party members are the only true Americans left.

51.04-0.21(-0.41%)Nov 21 4:00 PMEST

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