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rdawg;75410]I believe Histogen ends phase 2 in December, saying 2017-2018 is way too far. If all goes to plan histogen will be out come late 2014-2015 in asia/europe.
"If all goes to plan" . This rarely ever happens. To think that everything will happen right on schedule is unrealistic. Even if the trials WERE right on schedule, it would not be available immediately to the public that soon after it still has to get approved by the goverment agencies. They will take alot less time than the FDA , but will still take time. Phase II did not go exactly as planned and phase 3 will be larger and even more complex.
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Originally Posted by Person
rdawg;75410]I believe Histogen ends phase 2 in December, saying 2017-2018 is way too far. If all goes to plan histogen will be out come late 2014-2015 in asia/europe.
"If all goes to plan" . This rarely ever happens. To think that everything will happen right on schedule is unrealistic. Even if the trials WERE right on schedule, it would not be available immediately to the public that soon after it still has to get approved by the goverment agencies. They will take alot less time than the FDA , but will still take time. Phase II did not go exactly as planned and phase 3 will be larger and even more complex.
Well essentially we'll know by october if it's continuing to do well so assuming it will or won't work right now is just silly.
If it continues like it should it will be I believe in Phase III January 2013, I highly doubt that takes 5 years to release the product. Phase III should take no more than a year as it means the product is proven to work, it just has to be tested on a larger scale.
Anyways no point in arguing now as neither of us know, I just wouldn't expect it to take another 6 years if they're already having really good results right now. I personally expect early/mid 2015 Asia/europe, late 2016 north america.
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I heard/saw somewhere that Histogen is doing phase IIa and phase II b trials then a phase III. Does anyone know if this is true?
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Originally Posted by Person
I heard/saw somewhere that Histogen is doing phase IIa and phase II b trials then a phase III. Does anyone know if this is true?
Noone has clarified on this yet, I had the very same question.
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David Risinger - Morgan Stanley, Research Division
My question is for Scott. Scott, I'm hoping that you can comment on the timing for LATISSE for hair loss. On clinicaltrials.gov, it indicates that the 2 Phase III trials in men and women are supposed to be completing in September. So that's next month. Just wondering, specifically, what investors should expect in terms of communication i.e., would you issue a press release before you present data at a medical conference? Do you not plan to disclose that data at all? How should we think about being informed about those Phase II results later this year?
Scott M. Whitcup
Sure. So like you stated, we have 2 programs: one in typical male pattern baldness; and 1 in female hair thinning. Both of those trials are fully recruited. Our plan will be to present those data at medical conferences, and those should be next year. We won't have the data until just before that, especially for our Phase II program. We wouldn't plan to issue a press release, but are always committed to try to get those out into medical conferences as soon as we can.
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So basically we will hear nothing of the phase II results for the next 4-6 months
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Originally Posted by Person
So basically we will hear nothing of the phase II results for the next 4-6 months
Which makes perfect sense
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That Q&A exchange is a little confusing. The analyst asking the question is referring to Phase III trials on clinicaltrials.gov which sounds like a typo given the context. I only see Phase II trials on that site and they end in September .......(although I thought I recalled in an earlier thread that they were supposed to end in July of this year with results being available in September). Then Scott responds that "We won't have the data until just before that (meaning next year 2013), especially for our Phase II program." Why would he say "especially for our Phase II" program if there was only a Phase II trial?
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Originally Posted by Kiwi
Which makes perfect sense
Sarcasm?
I didnt think it took that long to show results. I thought the study ended in July and results would be available in Sept. So my guess is they wont even start Phase III until 2022?
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Originally Posted by PinotQ
That Q&A exchange is a little confusing. The analyst asking the question is referring to Phase III trials on clinicaltrials.gov which sounds like a typo given the context. I only see Phase II trials on that site and they end in September .......(although I thought I recalled in an earlier thread that they were supposed to end in July of this year with results being available in September). Then Scott responds that "We won't have the data until just before that (meaning next year 2013), especially for our Phase II program." Why would he say "especially for our Phase II" program if there was only a Phase II trial?
Its a typo, he meant to say phase II. Not sure why he said especially?
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