Feller, I believe that it's possible that a dru
Post# of 15624
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Posted On: 06/08/2017 10:56:25 PM
Feller,
I believe that it's possible that a drug that may benefit MM patients could be on the market this year, it's the sublingual tablet, but it will be years before such a product is approved for MM.
I believe it's the company's intent to use a form of the sublingual tablet for MM, but initially I believe they may need to do some testing on a variety of formulations of the tablet to determine what specific formulation provides the maximum benefit, that could take years, as MM patients live a substantial period of time, if they're not considered cures, do substantial observation time will be required. Once the best formulation is determined, a Pivotal Trial, either Phase 2 or 3 that was substantially larger would need to be done, that could take many years.
While all these trials are being done, nothing would prevent MM patients from using the sublingual tablet that should be in the marketplace later this year. Perhaps with sufficient anecdotal evidence insurance companies may even agree to pay for the drug, but the key is the medical community recognizing that some benefits can be seen from it's use.
I honestly don't know precisely how 0WCP intends to initiate testing for MM. Perhaps the criteria for trials isn't as rigorous in Israel, and perhaps .results can be achieved far faster. If that is the case, it's the way to go. If it's possible to prove it works anywhere, in time our FDA may come around. I simply don't know if trial can be done far faster and cheaper elsewhere.
Gary
I believe that it's possible that a drug that may benefit MM patients could be on the market this year, it's the sublingual tablet, but it will be years before such a product is approved for MM.
I believe it's the company's intent to use a form of the sublingual tablet for MM, but initially I believe they may need to do some testing on a variety of formulations of the tablet to determine what specific formulation provides the maximum benefit, that could take years, as MM patients live a substantial period of time, if they're not considered cures, do substantial observation time will be required. Once the best formulation is determined, a Pivotal Trial, either Phase 2 or 3 that was substantially larger would need to be done, that could take many years.
While all these trials are being done, nothing would prevent MM patients from using the sublingual tablet that should be in the marketplace later this year. Perhaps with sufficient anecdotal evidence insurance companies may even agree to pay for the drug, but the key is the medical community recognizing that some benefits can be seen from it's use.
I honestly don't know precisely how 0WCP intends to initiate testing for MM. Perhaps the criteria for trials isn't as rigorous in Israel, and perhaps .results can be achieved far faster. If that is the case, it's the way to go. If it's possible to prove it works anywhere, in time our FDA may come around. I simply don't know if trial can be done far faster and cheaper elsewhere.
Gary
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