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Cyclacel Pharmaceuticals, Inc. (CYCC) Message Board

  • lifetolive7 lifetolive7 May 18, 2013 7:15 AM Flag

    R-MDS phase 3 study....

    Because R-MDS patients have no approved treatment options that improve survival and the market is quite large (6X size of AML), an R-MDS study would fully enroll quickly. With the new capital, CYCC is in a position to put this trial in place quickly once the optimal dosing regimens are determined from the phase 2 trial and a formal design is agreed to by the FDA. Once that trial is in place, the FDA can consider an "accelerated approval" pathway for Sapacitabine in R-MDS. In my interpretation, there are no better examples as ideal candidates for AA than SAP in R-MDS. Interestingly, SAP may get to market for MDS before AML because there ARE other alternative treatments for front- line AML (although not very good ones). It's possible the FDA may award AA to SAP at interim results ( approximately 12 months from now if the data is strong enough). However, I believe R-MDS is the more clear cut case.

    Sentiment: Strong Buy

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    • Lifeolive7, appreciate your valuable messages. Not only do I admire your ethical behavior - despite the onslaught of personal attacks- I also appreciate the fact that you seem to be a shareholder in the good old sense. You believe in the company in which you hold ownership. Some people are here for the sake of their short term trading. They have little interest in the company , they are here for entertainment and see shareholding as a casino game. Pity they keep wasting our time .

      • 2 Replies to hanarets
      • If the recent offering gets us closer to the 850M R-MDS market sooner. That's a beautiful thing.

        Sentiment: Strong Buy

      • Thank You, hanarets, I think the way to look at CYCC is to understand the markets they will serve. Sapacitabine will be a very useful drug in oncology. I have done my homework and I am here for the distance. This is a hugely undervalued asset. We will reach an inflection point in the not too distant future where SAP is recognized by wall street. I have seen this action in many biotechs in the past. The same shorts show up on these boards. We could easily see 20 X our money here within 3 years.

        Sentiment: Strong Buy

    • Patience is the key here. The science and trial results have been impressive. I'm buying all I can.

      Sentiment: Buy

    • FDA does not require a phase 3 in place upon filing for accelerated approval. Typically they want one launched by approval decision. See Celgene phase 2 approval for pomalyst. They launched their phase 3, 6 months after filing for approval.

      If CYCC honestly thought MDS has a chance at accelerated approval, MDS should be AAAAA1 priority. Sapa AML is years away from filing for approval. If accelerated approval granted, MDS could be approved within 9 months. CYCC would totally focus resources toward MDS.

      Also, any accelerated announcement would propel PPS MUCH MUCH MUCH higher. The secondary would have occurred after such an announcement. And been 5-10x more beneficial. Required MANY fewer shares. And would have been warmly received by market.

      Sentiment: Hold

      • 1 Reply to valueinvestor411
      • I can only say that I have been told by a knowledgable source that the phase 3 trial framework needs to be in place. Perhaps CELG was treated differently due to the financial and political resources they have. I think the recent RMDS phase 2 results has indeed made CYCC look at MDS as a huge opportunity. The final published phase 2 R-MDS results should also be stellar and should be useful in their dialog with the FDA. I think we will hear something sooner rather than later. As for AML, we should be filing in early 2015 and the SPA will help expedite approval. I think the offering will be helpful in demonstrating to the FDA the resources to launch another phase 3 trial.

        Sentiment: Strong Buy

    • When studying a new drug, it can take a long time - sometimes many years - to learn whether a drug actually provides real improvement for patients – such as living longer or feeling better. This real improvement is known as a “clinical outcome.” Mindful of the fact that obtaining data on clinical outcomes can take a long time, in 1992 FDA instituted the Accelerated Approval regulation, allowing earlier approval of drugs to treat serious diseases, and that fill an unmet medical need based on a surrogate endpoint.

      A surrogate endpoint is a marker - a laboratory measurement, or physical sign - that is used in clinical trials as an indirect or substitute measurement that represents a clinically meaningful outcome, such as survival or symptom improvement. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

      Approval of a drug based on such endpoints is given on the condition that post marketing clinical trials verify the anticipated clinical benefit.

      The FDA bases its decision on whether to accept the proposed surrogate endpoint on the scientific support for that endpoint. The studies that demonstrate the effect of the drug on the surrogate endpoint must be “adequate and well controlled” studies, the only basis under law, for a finding that a drug is effective.

      Use of a surrogate can save valuable time in the drug approval process. For example, instead of having to wait to learn if a drug actually can extend the survival of cancer patients, the FDA might now approve a drug based on evidence that the drug shrinks tumors because tumor shrinkage is considered reasonably likely to predict a real clinical benefit. In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer. The drug company will still need to conduct studies to confirm that tumor shrinkage actually does predict that patients will live longer. These studies are known as phase 4 confirmatory trials.

      If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit for patients, FDA has regulatory procedures in place that could lead to removing the drug from the market.

      Sentiment: Strong Buy

 
CYCC
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