Thanks Bruce, What we need to remember is that
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Posted On: 06/09/2018 12:53:35 AM
Thanks Bruce,
What we need to remember is that the trials they've done on psoriasis were done preclinically. I believe they may have been done in other animals, but the psoriasis was human, but I really don't know the specifics of how it was done.
I frankly believe with the staff they have there, cannabis based formulations have probably been tried with people in finalizing the formulation, but companies never admit such experimentation. I know that an investor visited the company some time ago and spoke of being allowed to rub on some of the cream to see how it felt, he noted that it had an odor found in cannabis that rapidly dissipated as I remember it. I'm frankly uncertain if that occurred before, or after the trial began.
As for the Phase 2 and 3 Trials, if the safety trial virtually showed nothing blood borne from the cream, it would make sense that no blood testing may be needed and the trials could be based on observations, and frankly a set of photographs of the areas with the psoriasis would be sufficient to verify improvement. Much the same could probably be said about acne, etc, photographic evidence would tell the tale.
The question is, just how much data will regulatory bodies insist on to gain drug approval. Our FDA often has Phase 3 Trials that involve over 1000 patients, certainly it's not mandatory that it be that large, but the trial design will say a lot about how long the trial will take, and how much it will cost. I don't know if the initial pivotal trials will include the U.S., or if they'll try for approval elsewhere first, then come to the FDA and establish trials here. The positive side of that approach is that they'll have revenue from both drug sales elsewhere, and sales in cannabis stores here to support the cost of doing the trials here.
Frankly I don't think they did poorly with Sheeba, but they were very optimistic about how quickly things could happen. The delays the company has experienced are not that different from the delays I've seen in many biotech trials. It is rare that when you look at the clinical trials database when a trial is first scheduled that the trial starts, or ends on time, or even close to what's initially shown in the database. Once companies have done numerous trials their predictions may become somewhat better, but optimism is normal, as are delays, and investors need to expect it.
I believe the stock would be trading for over $1 if the company specified a firm date that they expect their first couple of products to be available for sales in any country. I specifically used products rather than drugs because sales may proceed actual drug approval and I believe we should differentiate between approved drugs and products which can be sold in cannabis stores. I believe we still have a two pronged approach which says that products can be sold before they're approved as drugs.
Gary
What we need to remember is that the trials they've done on psoriasis were done preclinically. I believe they may have been done in other animals, but the psoriasis was human, but I really don't know the specifics of how it was done.
I frankly believe with the staff they have there, cannabis based formulations have probably been tried with people in finalizing the formulation, but companies never admit such experimentation. I know that an investor visited the company some time ago and spoke of being allowed to rub on some of the cream to see how it felt, he noted that it had an odor found in cannabis that rapidly dissipated as I remember it. I'm frankly uncertain if that occurred before, or after the trial began.
As for the Phase 2 and 3 Trials, if the safety trial virtually showed nothing blood borne from the cream, it would make sense that no blood testing may be needed and the trials could be based on observations, and frankly a set of photographs of the areas with the psoriasis would be sufficient to verify improvement. Much the same could probably be said about acne, etc, photographic evidence would tell the tale.
The question is, just how much data will regulatory bodies insist on to gain drug approval. Our FDA often has Phase 3 Trials that involve over 1000 patients, certainly it's not mandatory that it be that large, but the trial design will say a lot about how long the trial will take, and how much it will cost. I don't know if the initial pivotal trials will include the U.S., or if they'll try for approval elsewhere first, then come to the FDA and establish trials here. The positive side of that approach is that they'll have revenue from both drug sales elsewhere, and sales in cannabis stores here to support the cost of doing the trials here.
Frankly I don't think they did poorly with Sheeba, but they were very optimistic about how quickly things could happen. The delays the company has experienced are not that different from the delays I've seen in many biotech trials. It is rare that when you look at the clinical trials database when a trial is first scheduled that the trial starts, or ends on time, or even close to what's initially shown in the database. Once companies have done numerous trials their predictions may become somewhat better, but optimism is normal, as are delays, and investors need to expect it.
I believe the stock would be trading for over $1 if the company specified a firm date that they expect their first couple of products to be available for sales in any country. I specifically used products rather than drugs because sales may proceed actual drug approval and I believe we should differentiate between approved drugs and products which can be sold in cannabis stores. I believe we still have a two pronged approach which says that products can be sold before they're approved as drugs.
Gary
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