I think we're all getting hung up on the duration
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Posted On: 10/20/2017 3:00:00 PM
I think we're all getting hung up on the duration of the safety trial. In reality, if it's true the trial was expanded with patients with a variety of skin diseases, the delay might prove very positive.
Here's my thinking. The trial was supposed to complete in July, but instead, at some point they determined to add the additional patients. In that the patients are supposed to be in the trial for 60 days, the trial cannot end until 60 days after the last patient is added.
If the trial ended on November 1st, it would mean the last patient was added essentially September 1st. If the decision to add these patients was made in the June to July time frame, it could take that long to attract a substantial number of patients.
Of course their is another possibility. Once they tried the cream on the first, or first few patients with a certain skin disease, they were so impressed with trial results that they determined to add even more patients, further extending the trial. I'm not saying this is the case, it's purely speculation, but remember the decision to suggest such an expansion would come from the clinicians who still wouldn't reveal the precise details of the results to the company, what they would reveal is results are so positive as to recommend increasing the size of the trial.
I know nothing about the Israeli approval process, but suspect it can be far more streamlined then our process. I don't know that it would be impossible to expand this Phase 1 Trial to the point an approval is possible. Remember, the cream they were using is of commercial quality, so their is no issue about the material not being suitable to a pivotal trial.
The point I'm trying to make is that the longer the trial is delayed, the stronger the evidence that comes out of the trial may be for supporting the use of this cream in a variety of patients. Is it sufficient for Mediq to begin sales in Germany practically immediately, I certainly cannot say, but given what people who've spoken with Mediq have said, I don't know that it can be ruled out.
Perhaps we'll be given some guidance at the next quarterly report, but if they maintain that they cannot because of confidentiality agreements, I can only say that in the end the expansion of the trial and delay in concluding it may be exceptionally positive news when it finally completes.
Gary
Here's my thinking. The trial was supposed to complete in July, but instead, at some point they determined to add the additional patients. In that the patients are supposed to be in the trial for 60 days, the trial cannot end until 60 days after the last patient is added.
If the trial ended on November 1st, it would mean the last patient was added essentially September 1st. If the decision to add these patients was made in the June to July time frame, it could take that long to attract a substantial number of patients.
Of course their is another possibility. Once they tried the cream on the first, or first few patients with a certain skin disease, they were so impressed with trial results that they determined to add even more patients, further extending the trial. I'm not saying this is the case, it's purely speculation, but remember the decision to suggest such an expansion would come from the clinicians who still wouldn't reveal the precise details of the results to the company, what they would reveal is results are so positive as to recommend increasing the size of the trial.
I know nothing about the Israeli approval process, but suspect it can be far more streamlined then our process. I don't know that it would be impossible to expand this Phase 1 Trial to the point an approval is possible. Remember, the cream they were using is of commercial quality, so their is no issue about the material not being suitable to a pivotal trial.
The point I'm trying to make is that the longer the trial is delayed, the stronger the evidence that comes out of the trial may be for supporting the use of this cream in a variety of patients. Is it sufficient for Mediq to begin sales in Germany practically immediately, I certainly cannot say, but given what people who've spoken with Mediq have said, I don't know that it can be ruled out.
Perhaps we'll be given some guidance at the next quarterly report, but if they maintain that they cannot because of confidentiality agreements, I can only say that in the end the expansion of the trial and delay in concluding it may be exceptionally positive news when it finally completes.
Gary
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