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This is the same thing that happened to AVXL and many other biotechs that are on the cusp of something big. They file frivolous law suits and then the short attacks increase as they try to scare everyone into selling. I suspect they're trying to get the price down while they continue to accumulate. Yawn...
Not necessarily. If they requested additional data, then they neither approved or rejected it.
I agree, especially since BTDs are often given during the P2 trials to help expedite the P3 trials. I can only assume that given the adjunct trial is referred to as P2b/3, they're treating it as P2 with the goal of getting approval and hoping it will expedite the P3 mono trial and final FDA approval. And, of course, getting the BTD makes it much more marketable for a BO.
Got it - thanks!
Thanks for letting us know, Bud. Our thoughts and prayers are with his family.
On an unrelated note, I took a look at some of your previous posts to refresh my memory on some of your previous comments because your posts are always interesting and informative. I found the following comment that you posted on Dec 12 that is especially interesting given that we may be getting an update on the P3 adjunct trial in April.
Great post, Saltz! Thanks for being the voice of reason. Many people invest in biotechs for the big win, however they don't understand the business, and constantly lash out at management when things don't move along fast enough to make them rich quick. This is the wrong place to be investing their money if they're looking for a fast buck. The biotech sector is the most highly-regulated industry out there, and there are too many factors that determine the pace, including the CROs and FDA. I suspect we'll get a PR when they're ready to update us, and a not a minute sooner. Just because we haven't heard anything doesn't mean it's negative or they're hiding anything - it just means they're not there yet.
Ah, yes...I remember this post. This was the one you posted just before you had a melt-down and called everyone on this board "a bunch of idiots" only to have your post deleted. According to you, no insider buying. And according to me, no insider selling. So what's your point??
Here's the part that I like about Charlie's interview:
Doing well: In December, the outlandish star revealed exclusively to Daily Mail Online that his involvement in a clinical trial for the drug PRO-140 has helped to achieve complete suppression of the virus.
The Anger Management actor exclusively opened up to Daily Mail Online in December about the clinical trial drug used in his treatment. Charlie has been involved in a clinical trial for the drug called PRO-140 since early 2016.
As opposed to traditional antiretroviral therapy (ART), which involves taking daily medication, Charlie receives a weekly injection that has no side effects.
In December, he received the news from the head of his clinical trial that he has achieved complete suppression of the virus using this method alone.
All stocks took a hit today including biotechs. The IBB was down ~3% which is fairly significant. We'll jump back up with the market tomorrow or later this week.
Earlier this week, you said the following:
Quote: There were 12 BTD applications from Oct'16 to Dec'16 - 2 approved, 4 rejected and 6 applications are still pending. That is more than 60 or 90 or 120 days.
I asked you the following question: When was this last updated? I'm only asking because if the 6 that are still pending applied in Dec, and this hasn't been updated since mid Feb, then I'm not sure how you came to the conclusion they are 60-120 days late, or even late at all.
Update: I found the link - it hasn't been updated since Dec 31, 2016. Which means NONE of the BTD requests were late. Your comments were misleading, at best.
Here's the link:
https://www.fda.gov/downloads/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/UCM485141.pdf
Bingo!
Saltz - do you have any idea as to how many of the warrants are still outstanding? I suspect that is where they'll get a significant cash injection after the jump in sp.
Um...so you paid 6 cents per share? How did you do that?
Welcome to my Ignore list.
This is purely speculation on my part, but I don't think BTD was a priority a year ago because they were optimistic on the timeline for recruiting patients for the combo trial. Assuming we're close to completing the enrollment for the adjunct trial, I suspect mgmt's goal (don't forget, we have a new driver now) is to get the BTD and hope the FDA will expedite the P3 mono trial review and approval, assuming we haven't been purchased by then - call it "Plan B". I may be wrong, but I think the FDA can agree to end a P3 trial early if the safety and effectiveness are well demonstrated, and with low risk which is what we're now seeing in the adjunct trial. This would shorten the P3 mono timeline given there are 300 patients to enroll and monitor. The BTD submission also dovetails into their recent manufacturing agreement with CMC. I think Caracciolo is gearing up for early approval and creating leverage for any current/future BO conversations. You can bet he's not sitting around like a potted plant.
This is from the FDA website - I don't see where extending the 60 day deadline is an option:
I see the Sheikh left a comment this morning: