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That's "alluded", although I'm sure they would love to elude a requirement for two pivotal studies.
That's a bit harsh- RP is equally inconsistent with inaccurate information.
I see that the famous Gibson time dilation effect is still in effect. Good show if the validation study will complete early, but since there is no fixed timeline for a full COA qualification package review (and with the current street estimate being 6-10 months), a Q1 2020 start for pivotal study work is pretty nigh impossible. And let's not dismiss the risk around submitting what is no more than a pilot study for an otherwise untested endpoint.
Assuming there's not a typo in the dates, you are looking at the shortest Phase III and NDA submission in history:again, pretty nigh impossible. RP have eluded to a single pivotal study, but outside of cancer and high need conditions, the FDA requires two studies (and historically, this has been the case for the few PE pivotal studies submitted in the last decade). And when are they planning to address the combination product rule question?
China timeline is close enough - 60 day IND review if nothing amiss with the submission, but there's no allowance for a pre-IND submission meeting, so add another 30-60 days and call it sometime late Q1 2020 until the NMPA response. Still no mention of the Taiwan FDA bridging study requirements.
As for the possible involvement in indigenous hemp/CBD production, hard to evaluate without more detail. Hemp production and CBD extraction are strictly regulated but there appears to be an increasing number of licences granted to Chinese companies. Hemp seek, oil and CBD are legal for use in cosmetics (but not ingestion), and not for medical use
The Chinese require animal testing for cosmetic approval (leading to a complex importation route for foreign cosmetics, although readily navigated by the majors) and no medical or wellness claims can be made that might assist with product differentiation. Chinese cosmetics do not meet EU or US conditions, so not possible to export finished product. So, all down to hemp/CBD export from China into increasingly competitive/self-sufficient markets?
Unfortunately, ‘Mr Know It All’ is invariably able to respond quickly because RPG are so inconsistent with accurate information that they play into his hands. It is easy to haul this company over any number of coals given their complete ineptitude.
Firstly I'd like to ask. what about Orient and HK/Macau. surely those two launches are much further along than either the FDA or the China syndrome or even a new acquisition ?
Matt,
The start of the phase 2 was delayed from July until Dec, but if that delay is anything to go by. (JG informed the market and later me by email after I noticed the FDA gov website was indicating still no recruiting in August, that all was on schedule). An utter BS response with no knowledge of what was going on since it was then delayed till Dec.
I'm not sure about the new route. My understanding was that at least Yooya would not just be limiting itself to China, whereas this update indicates the new company will be in China, yet all my research so far has indicated that although China is one of the worlds largest industrial producers of Hemp, they still have not approved CBD for medical use. Please correct me if I am wrong. Unless they are only looking to China to supply Hemp ?
https://en.wikipedia.org/wiki/Cannabis_in_China
I assume it wont be too long before Mr "know it all" responds to the FDA update. Anyone want to have guess as to how long before he posts again with his narcistic views ? My guess is within the next hour or 2.... ;-)
http://www.regentpac.com/ICMServlet/download/13-2286-3726/EAnnt-YooyaTermination(18Jul2019).pdf
Latest update today:
Have I read it correctly?
US update looks as though it is now 6 months behind schedule compared to July 2018 update or have I misread?
I am pleased though that they had a second plan on the table after the yooya deal didn't work out.
At least there is some effort occuring there to begin the process of adding to the RPG portfolio.
This announcement looks more promising and highlights less dilution to shareholders. There is enough there to add some interest through the next quarter or rather late 2019 and into new year. Fingers crossed in ignites greater opimism in Hong Kong