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My guess there is simplicity. They probably have a general agreement worked out with Paulson - terms that both sides have agreed to for some agreed upon amount that CYDY can keep going back to the well for. That would give CYDY flexibility and make them a little more nimble in capital markets than if they had to renegotiate everything every time they wanted to raise a month or two worth of cash. This would be very advantageous for a small company without many capital markets options.
Speculation to some degree, but I see that as a good thing. To me, it means they think that they're close, and are raising cash in the most simple, piecemeal way that they can. Paulson is willing to keep putting in cash at the same terms, meaning that even with dilution they still see the profit potential as solid.
Not looking forward to price movement today, but I'm holding the course. Mid-March with no BTD would be the time to make some decisions, in my opinion.
8k from this morning: http://ih.advfn.com/p.php?pid=nmona&article=73970806
From the Q&A I referenced a few posts back:
Unidentified Analyst
Yes. Hello. I just have a quick question regarding P3 combo. I know we only have 12 enrolled and your anticipation as we can get the other 18 enrolled in Q1 along with primary efficacy point, which is the one we follow-up? Why are you so optimistic about getting 18 when it’s taken so long to get the first 12 of that in all respectfully? Thank you.
Nader Pourhassan
No. Very good question actually. Thank you. When we first started this trial we immediately stopped our processes as we were enrolling hospitals and then back to FDA and asked instead of having three drug resistance let us have two drug resistance, that process when you send a letter it takes 30 days waiting and then you get it and you have to train all the sites again. Then we went back to FDA say let us have one drug resistance and when you go through all of these processes it took us about a year, doing all of these and as we got where we need to get, which is reduce number, during this one year we enrolled 38 sites and hospitals.
Now if you check with any institute or any CRO, enrolling hospital, two or three per month or maybe four or five per month is a lot. So we were working on getting the hospital situated and now they are very excited and they are able to find the patient. And the fact that we have 13 patients in the screening and these 38 hospitals just need to give us one patient per hospital and that’s 38, not counting the 13 in the screening.
We talked to our senior clinical person and he is very optimistic that we can have this. Obviously, we are not saying that this is 100%. We need to see how it folds out. But it’s very positive and we went through Thanksgiving and Christmas and we still enrolled. So I think these numbers are very exciting and we are going to be able to have our primary endpoint first quarter as we have said before.
Link here: http://seekingalpha.com/article/4034678-cytodyns-cydy-ceo-nader-pourhassan-hosts-investment-community-conference-transcript?part=single
I seem to remember in a Q&A session sometime that NP had fairly solid reasoning around the slow enrollment activity, and reasonable expectation that the enrollment rate would pick up significantly. Something about getting sites/facilities online first, not rushing enrollment while working with the FDA on protocol, etc. I bet someone here has that transcript handy... If nobody has it I'll try to look for it later on, won't be in the next few hours though.
In other news, anemic volume today...
For those who have followed biotech for a longer period of time... how often does the FDA take less than the allowed 60 days to rule on a BTD request? Or do they usually take the full 60 days, or close to it? I haven't been able to find any numbers on that sort of thing. Thought it may be an interesting data point, thanks!
Thanks for the information Dew, much appreciated. Interested to hear your take on the possibility of significantly reduced adverse effects with a new treatment option. If you set aside patient compliance and efficacy as roughly equal (oversimplification, of course), do you think a preference towards lack of potential hepatoxicity, immune function impairment, etc, might be enough to make a new treatment more commercially viable?
Obviously hypotheticals, but hey, I'm not trying to sell a company to anyone on this board. Just interested in different opinions and trains of thought. Appreciate the GILD folks here letting me crash the party for a few minutes.
Bucky, I've missed tap-ins and watched the pros do the same. At the risk of sounding like a cheerleader, I'd call combo a gimme from the FDA. The FDA makes the rules for the clinical trials, and they set the bar really, really low on this one. All but gave it away. Mono, slightly different story, but hey... I think this'll be sold long before mono results are in anyways.
I'll put away my pom poms now and grab some popcorn.
Thanks for the PM! Don't have the ability to PM back, unfortunately, but I got yours.
Appreciate the info. Thanks, you as well!
Could be, and I would think that there are other companies that might have interest. Recent earnings analysis on GILD's falling sales in HCV, coupled with an upcoming HIV patent cliff, made me think that this might be a nice play for them over 10 years. They've got the HIV market for now, have the physician and marketing network, and could use a potentially disruptive new drug to solidify that market past the next 2-3 years. That'd be nice support for their baseline outlook.
Always interested in any opinions or thoughts though, contrary or otherwise, so I appreciate the discussion.
Eh, I'm not going to get into all that. I think that many folks on this board probably just have their minds made up at this point and are waiting for the ball to drop. It's been a long road for some apparently, and they probably don't have much to discuss re: PRO 140 at this point short of big announcements. That's fine. I've gained a lot of information from reading the board, as well as links like the ones you've sent out and I've just been sent on GILD.
By the way, I've (along with a friend) tried several times to contact Corporate with no success. Still interested in a more detailed report out on anything you heard from them.
I appreciate all of the good conversation and due diligence from all sides, and can even appreciate the occasional tangent about horse racing and karate. Life is too short to care if someone disagrees with you on the internet.
Saw that, much appreciated. Probably not going to convert anyone who thinks otherwise, but that's fine. DD's points about the need for an assay on strain of HIV by patient at least made me think about the fact that I've taken CYDY's numbers on the percentage of diagnoses that would be candidates for PRO 140 for granted, so now I'm researching that a bit to confirm what I think I know. Any independent numbers on that front while we wait for the news we're all hoping for and expecting?
Just trying to see who's thinking what out there... Seems like an obvious move for GILD, so I'm surprised to see that nobody over there is really thinking about it. Then again, maybe I'm just too on board with this to see what others see, and someone can talk me out of buying the mini-dip to 0.72. Again.
Might hit the GSK and MRK boards for fun as well, see if anyone there has thoughts or perspective. They both have motive and opportunity to poach market share from GILD.
Interesting - thanks for the response and the link. Not sure I completely agree, as Selzentry has many of the same drawbacks as HAART (daily regiment, severe adverse effects, etc) even though it acts on a similar mechanism (CCR5 antagonism) as PRO 140. What makes you say that it would only address a small slice of of the HIV market? It's my understanding that ~90% of new diagnoses in the US, and maybe as high as 70% of existing diagnoses, would be candidates for PRO 140. Both of those things would make it fairly attractive, in my mind. Always nice to hear a contrary opinion though - food for thought is a good thing.
Agree with that assessment in general, Ahab, but it doesn't negate his point that PRO 140 needs to get to market as fast as possible. It's a market share game, to some degree. That said, I agree that approval is close, and the tea leaves would seem to indicate that a buyout is potentially closer. All likely good news for anyone long CYDY.
Appreciate the link, Grip It. Context is always a good thing.
What are you suggesting, Tonecee?
With all of the acquisition talk on this board and in general chatter, has anyone got thoughts on CYDY as a potential buy? PRO 140 is in Phase 3, seems to have FDA support, and appears to have the potential to be disruptive in the HIV market. Low market cap, could be a relatively cheap way to lock up HIV profits as existing patents expire.
Apologies if this has been discussed here before. Didn't read but so far back in the posts.
That tells us nothing of what you actually heard from corporate... I'm sure may folks here would be much obliged to know what was actually said.
Interesting. I'd be interested to hear a more complete wording of what you got from corporate. Honestly seems like the sort of information that they would be... reticent to share.
Now THAT would be some worthwhile information on the margins...
Thanks for the context - much appreciated. Was traveling this morning and didn't catch the abnormally low early session volume today.
Grip It, why the thought that volume could bounce around 3:30 today? I see you've already noted a jump in volume after your original comment, but that doesn't answer the question of "why today?" Just curious and trying to piece together any info that may be out there. Despite what I gathered that some may think of my identity/newness to the board/intentions, I'm very much my own person and solely interested in objective information on the margins. I also very much have a vested interest in CYDY doing well.
Interesting. I wasn't able to follow CROI but so closely, so I was a bit unaware of GILD's apparent disinterest in the HIV arena. Appreciate the insight.
Hi Pearsby, I think we may have miscommunicated. GILD didn't buy the drug, they bought the priority review voucher (PRV). Sarepta sold the voucher (which is legal for some reason) because the drug for which they were granted the voucher (Exo 51) was actually approved before the voucher was used. The voucher allows Gilead to submit a different drug for approval under priority review. For example, review the table about halfway down this article:
http://camargopharma.com/2016/07/tropical-rare-pediatric-disease-priority-review-vouchers-update-use-505b2-pathway/
You'll see that Rare Pediatric PRV have been bought and used for high cholesterol drugs, Type 2 diabetes treatments, etc. I'm not even sure now that GILD has to use it for a Rare Pediatric Disease. It just allows them to bring a drug to market more quickly. Which looks perfect for a case like PRO 140 which still has some runway to market, but where CYDY may be looking to sell. PRV would lower GILD's cost of bringing a late-stage drug to market, and get it there faster.
Or maybe I'm misunderstanding. Thoughts?
First post here, have enjoyed following the discussion though. Saw this in the news today:
http://www.fiercebiotech.com/biotech/sarepta-sells-exondys-51-prv-for-125m-aims-to-use-cash-for-duchenne-r-d
Anyone have any insight as to whether HIV may qualify through some loophole as a rare pediatric disease? I'm not sure GILD has anything else in their pipeline that may fit the bill, and would potentially reduce the cost/time to market for PRO 140 if they were to buy out CYDY. Seems like an interesting purchase for GILD if they don't have a drug acquisition in mind.