Too funny. You know that the FDA calendar does not include OTC/pink companies right? Generally it includes AMEX and Nasdaq listed companies.
Nothing. We are still waiting, that's all I see the update as. There was never an approval date, just when the FDA was satisfied. They answered the CRL just like the FDA wanted, but now thet have additional requests. They did not reject the CRL.
In terms of raw material, they are being proactive in finding another source. They don't want their eggs in one basket. I'm simply going to do the same thing as last week, which is hold. If it drops...that's the best news thus far.
If I can grab more in the $.70s, or lower, then today's news is a win all-around. GL.
Why do you care so much for people that you only know by Yahoo screen names? I could give a #$%$ about anyone here, but you seem to care so much for your fellow man. You put in sooooo much effort, so why do you care so much?
I like your enthusiasm, but today was not a run up and there won't be news Monday. There is no news to report right now...
Sentiment: Strong Buy
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Here is my comment:
"So you shorted the stock and wrote this to benefit your position? You planned on it sinking from a "bad" CC, and now your losing money. I love your final advice on this ridiculous article: "So, as always, trade accordingly." You should listen to your own advice."
1. He stated he shorted the stock
2. His argument is that after the bad CC the stock should have gone down, not up.
3. He posts this article after the stock has risen after the CC.
4. His points are ridiculous IMO
I am not sure where the comment was wrong...oh well.
Is this it?
"There are no additional questions at this time, so I’d like to turn the call over to Mr. Mann.
Alfred Mann - Chairman of the Board, Chief Executive Officer
Thank you all for joining us today, and we look forward to further communication with you in the coming weeks and certainly in April. Thank you all."
I believe they are looking at (2) possible partnerships or (1) partnership on two compounds which was just recently noted. This may be a big surprise if this pans out to be true. See the recent article and the slide from the recent Biotech event.
Following Unmet Needs To Biotech Profits: Echo He:
"EH: I did talk to management recently. The company will probably report some data on its two phase 1 candidates during 2014, but not on the phase 2 trial for Archexin. One catalyst might be a partnership with a big pharma on the two oral compounds in phase 1. "
During the Bio Conference they said they only were looking for (1) partnership or compound, see slide 24.
Biotech Showcase 2014:
"Complete RX‐3117 corporate partnership (mid year)"
"IntelGenx and RedHill further believe that the majority of issues raised by the FDA were recently addressed in an amendment submitted by the companies to the FDA that has yet to be reviewed."
Yup just packaging, labeling, and manufacturing. That's obvious though. They are a Canadian company co - developing a delivery mechanism with a company in Israel. They will choose a partnership very soon to address this IMO.
I agree, a partner will help solve any additional questions by the FDA. The drug needs no further clinical trials is the bottom line. Labeling, packaging, and manufacturing are minor issues.
Exactly it's approved, they just need more info on third party labeling, packaging, and manufacturing. That will be done in just a few weeks then comes partnership.
I would be happy to simply close in the 1.20's tomorrow. The faster we move up the faster the shorts will pile on.