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Onconova Therapeutics, Inc. Message Board

oncology908 63 posts  |  Last Activity: 23 hours ago Member since: Oct 31, 2013
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  • and pockets the difference under $3.50 they will run the PPS right back up over $4.

    Watch and learn.

    Sentiment: Strong Buy

  • oncology908 oncology908 Apr 3, 2014 7:16 PM Flag

    L2L, the only way I see the S3 as good is if there soon will be an announcement that the FDA has approved a RMDS p3 clinical trial design........preferably under a SPA. This would raise the PPS and allow the raise to fund the trials. AA looks unlikely because if it were to happen they wouldnt need the cash. I see the news as neither good nor bad. CYCC share holders so far are taking all the risks on SEAMLESS and it appears as if they will now take all the risks on the RMDS phase 3 trial.

    Sentiment: Strong Buy

  • That is that Spiro has not been able to obtain any decent licensing arrangment for the RMDS indication and plans on going it alone thru phase 3 trials no different than what he decided on SEAMLESS and the AML indication. It tells me that they want to get this indication going ASAP and not wait. They have enough $ for SEAMLESS but there is no money for RMDS which is an even bigger indication. This does not mean anything good or bad except that CYCC is remaining independent from BP when it comes to moving the RMDS indication into p3 trials.

    Sentiment: Strong Buy

  • I suspect they have something in the works near completion regarding a licensing partner for sapacitibine. I expect one day we will just have a PR before the bell and the PPS will go nuts. Anyone who understands the science here will buy while the PPS remains at severely depressed levels knowing that there are mutiple shots on goal for price appreciation.

    Sentiment: Strong Buy

  • How about a vote of confidence CYCC managment?

    Sentiment: Strong Buy

  • oncology908 oncology908 Mar 27, 2014 11:15 AM Flag

    I will agree with you that he is "brilliant" after he signs a marketing deal for sapacitibine in both AML and RMDS indications similar to what Pharmacylics did with Janssen several years ago. Stock moved from $1 to over $150 in 5 years and probably proved to be one of the best biotechnology investments after the 2008/2009 crash. I'm not saying we will be a $150 stock but this sub $4 trading pattern is a joke considering the future potential of sapacitibine for multiple oncology indications. CYCC is not getting much love these days. I thought by this point in the game it would be trading at least over $5 and maybe as high as $10. The current price tag on the shares is beyond disappointing considering the piepline progress to date.

    Sentiment: Strong Buy

  • Carrot waving on Spiro's part or do you think they actually are taking any input or guidance on the RMDS indication from potential BPs who are telling Cyclacel how they think they should proceed if they are to sign any licesning agreements for this indication?

    Sentiment: Strong Buy

  • oncology908 oncology908 Mar 27, 2014 10:25 AM Flag

    dup, just my opinion but perhaps along with the ONTX failure, the FDA is waiting upon some more input from key opinion leaders in this field before giving CYCC any green lights with something like Accelerated approval. Who knows but if the KOL are pounding the table for AA then perhaps they could get it? I'm not saying this will happen but when you consider the high death rates and alternatives after HMA failures(basically nothing) and you have data supporting a doubling of surival times, what do you have to lose? there is enough safetydata on sapacitibine and so far the efficacy data is highly suggestive that the drug works to prolong survival.

    Sentiment: Strong Buy

  • oncology908 oncology908 Mar 27, 2014 10:06 AM Flag

    Maybe the FDA will grant approval and then concurrently make them run a phase 4 clinical trial on the patients actually taking the drug to see their surival times comparing to BSC patients? I think the problem here is that there are no solid studies which have documented survival times on HMA failures with BSC and the numbers that have been put out there are based on times given by MDs who treat the disease as approximations only. That seems to be one of the big hurdles the company has already mentioned.

    Sentiment: Strong Buy

  • oncology908 by oncology908 Mar 27, 2014 9:56 AM Flag

    that we are not yet on enough radar screens but the timing is getting close. With enrollment now at 60%, a fourth DSMB review in weeks and futility analysis after that, the stock with its puney valuation will not go on ignored too much longer. The other ace being held by longs over the shorts is that nobody knows when the company might announce a licensing deal. If they do like SNSS they would have a deal signed a few months after this next DSMB review comes out.

    Sentiment: Strong Buy

  • Reply to

    Company's silence is deafening

    by breakingaway14 Mar 12, 2014 12:45 PM
    oncology908 oncology908 Mar 12, 2014 1:23 PM Flag

    This is a quiet period before earnings. We should get a PR for the earnings call date this week. What I think is going to happen is they will hold their CC and inform the investors of what the FDA has agreed upon for protocol for the RMDS trials. Although everything will be on track concerning SEAMLESS progress, some will be disappointed because no licensing agreement will be announced. Then some time in Q2 they will announce at least one licensing agreement that will help increase the cash levels which will cover the costs of the RMDS trials. Those are my expectations anyways. Maybe you are right and a licesning agreement could be announced during the call and they are delaying it a bit to get everything signed and sealed but I wouldn't get my expectations up too high. The stock now appears to be under light accumulation and perhaps some are buying with the hopes of good returns by no later than next quarter.

    Sentiment: Strong Buy

  • Things are awefully quiet at Cyclacel lately. I wonder why?

    Sentiment: Strong Buy

  • Maybe this will change when they clarify their registration path with the FDA for the RMDS indication?

    Spiro appears to me to be laying real low lately. He doesn't even participate in as many investor conferences as he used to a couple years ago when the pipeline was less developed. I think he has something up his sleeve.

    Sentiment: Strong Buy

  • oncology908 oncology908 Mar 3, 2014 10:26 PM Flag

    Good post. Obviously Spiro expects to be informing CYCC investors on the registration path some time this month otherwise he would not have bothered mentioning it at his last presentation 3 weeks ago. He said in "several weeks". To me this means we should know any day now but I expect they will either do a PR when things are finalized or at the very latest we will know on the Q1 conference call. I expect there will be a PR on it soon if the CC isn't until later in the month. I think clarifying the RMDS registration path will bring in new investors because they will then see that CYCC has not one but two shots on goal. If SEAMLESS succeeds the stock is going a lot higher. If Spiro licenses SAP for any indication the stock is going a lot higher. As time progresses the likelihood of a licensing deal increases and it should eventually start to be reflected in the PPS.

    Sentiment: Strong Buy

  • Has Cyclacel given any time estimate for approximate date on futility analysis ie 212 "events" or deaths?

    Sentiment: Strong Buy

  • oncology908 oncology908 Mar 1, 2014 6:55 PM Flag

    L2L you stated that, "Rigosertib was found to only be effective in lower blast MDS populations 6-10%". I am wondering why ONTX said the trial was for "higher risk MDS"? Wouldn't the "higher risk" patients be those with the 10 to 20% blast counts? Or did they do p2 in the 0-10% group and the p3 trial in the 10-20% group?? At any rate, the more I study the facts here the more I think we are sitting on a huge winner with CYCC.

    Sentiment: Strong Buy

  • oncology908 oncology908 Mar 1, 2014 5:03 PM Flag

    Onconova Announces Results From Phase 3 ONTIME Trial of Rigosertib in Higher Risk Myelodysplastic Syndromes (MDS). value, this is the title of the ONTX PR. The quote you mentioned was in the actual wording of the PR referring to the subset of patience that had a significant response. The way I read it is that the study was not intended solely for patients with MDS already being treated with hypomethylating agents(refractory of not) but "high risk" MDS. I assume they define "higher risk" by the blast count of the patients enrolled.

    Sentiment: Strong Buy

  • oncology908 by oncology908 Mar 1, 2014 1:42 PM Flag

    ONTX IPOed at $15 a share last July. They ran the stock up to over $31 a share after the IPO only to dump the stock down to under $11 in January. The stock then did rebound back up to $15 before the trial data was announced. One has to wonder if someone didn't know something about the data when the stock had such a steep drop late last year? Looks like it then had a speculative pop before the actual results were announced.

    Other point of interest is that Janney Montgomery(whose analyst covers CYCC stock) was one of the co managers in the IPO. At $15 a share ONTX had a market cap of over $300M or four times that of CYCC.

    Sentiment: Strong Buy

  • My understanding is that the Rigosertib trial was supposed to be a study of high risk MDS as a front line treatment and not as a refractory MDS treatment? So why did they have patients who progressed on or were refractory to hypmethalating agents in the clinical trial in the first place? Seems like they are now cherry picking the subset of patients that progressed on or became refractory to hypomethelating agents and now will probably attempt another p3 trial which will be for patients that progress on or were refractory to hypomethelating agents.

    Another thing that I would like to know about the Rigosertib trial was the age of the patients treated. CYCC is shooting for refractory MDS patients that failed on hypomethylating agents only. CYCC is also shooting for elderly patients that refuse to or probably can not tolerate further IV drugs that have a high chance of actually killing them sooner than help prolong survival.

    Regardless, it appears that we should know about the CYCC RMDS trial design very soon. If they were waiting for further Rig data for trial design then that would contradict what Spiro said at the BIO investor conference.....ie that the company would be revealing the trial design in "several weeks". ONTX clearly blew the trial and now is calling attention to a smaller subset of patients which includes patients that improved OR were refractory to hypomethylating agents and we do not even know the ages of this subset of patients. The CYCC phase 2 trials had the BSC control arm and the treatment arm is elderly patients that were refractory to hypomethylating agents. CYCC appears to have been right on target from the get go. ONTX now appears to be well behind CYCC if they plan on proceeding with another trial where the treatment arm will be patients that are improved on or refractory to hypomethylating agents. Who knows they may decide to run a trial that only includes one of those two patient subsets?

    Sentiment: Strong Buy

  • I believe WS will be a sheep like buyer/followers once Spiro licenses SAP for any territory for any indication. Once he delivers they will jump all over the stock and it will make its rapid move to $8 no different as it did when they released the RMDS data 18 months ago. This is where the company made its largest error. In the fall of 2012 they should have prepared to do an offering right before releasing the RMDS p2 news. They could have done the offering at $8 not $3. It was a huge error on their part but now it is water under the bridge.

    Sentiment: Strong Buy

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