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Leadership change underway at GILD:
https://finance.yahoo.com/news/gilead-ceo-milligan-chairman-martin-202843097.html
Interesting observation... let’s hope history repeats itself, shall we?
I’ve been thinking that it’s about time... volume seems to indicate that it may be the case. Hope so, anyway.
Congratulations! Truly happy for you. Finest root beer in the house on me when this plays out.
...I feel like I’m in the bizarro episode of Seinfeld right now. I think everyone (except chump, of course...) needs to settle down and have a drink.
Regardless of timelines, you and I both know that’s not the plan for the order of events.
Very interesting. Puts a little twist on things.
Appreciate you reporting back on what you heard!
I can’t attend - please do update us after the call. Thanks in advance.
I would love to have more context around the recent IDMC review of the GvHD trial. What did the FDA actually say? We’re the proposed protocol amendments accepted wholesale, or were there negotiations? How did they agree to the shortened time frame of 30 days post-treatment? I doubt you’ll get answers here, but I’d love to ask the questions.
Beyond that, I’d want to ask about:
- Funding... but you won’t get answers. Same with acquisition details, starting cancer trials, further thoughts on MS, etc.
- More details on the plan for increasing dosage in mono. Do they have another soft target for efficacy from the FDA? How many do they expect to enroll new vs. convert from lower doses? Expect a 48-week observation will be necessary again? Would 48 fresh week’s be required for converted patients?
- When do they expect to have a meeting with the FDA regarding investigational vs. pivotal for mono?
- What specific CMC issues do they expect to encounter for combo BLA?
Appreciate you making the effort, and I look forward to hearing how it goes if you have a chance to discuss things with him.
This is 100% accurate regarding the facts of the trial(s) as laid out in the call. Thanks for posting this.
I tend to agree with you that the FDA seems to like what they see. However, what the FDA will actually do is pure speculation currently. That said, I believe that Pourhassan is choosing his words and timelines extremely carefully and conservatively at this point. As well he should, based on history.
Boulder was tough, the weather got the best of me. Very, very hot, with some good headwinds on the bike. I ended up badly dehydrated despite my best efforts and struggled through the second half of the bike and the entire run. I finished, but far short of any goals past the swim. All in all a very cool experience, but I’m not sure I’ll do another due to the level of commitment leading up to it. I am signed up for he Boulder 70.3 on 8/4, so I’m hoping for a little stronger day there. Appreciate you checking in. You doing any racing?
It is nice to have such a variety of backgrounds on the board. Everyone contributes significantly in (at least) their own key aspect.
And the pleasure shall be mine the following night.
Appreciate that, and it’s my pleasure. Always appreciated your input as well. I get a lot of help from my group in thinking these things through though, so there are a few others who deserve that credit as well.
Careful, I may just take you up on your offer... and it’s looking more like we absolutely will be cashing out one day.
I tend to agree with your general premise here. To me, the wild card is what funding they absolutely know Pestell can bring in. If his credibility and presence get the company the significant and non-dilutive funding they need, and they KNOW this ahead of time, he’s worth more than he would be otherwise. The closing of the merger could easily be contingent on simultaneously closing a funding deal.
At the end of the day, we just don’t know. Too many moving parts. All that we all seem to know for sure is that if you buy shares at $0.60, you’re going to make money eventually. The company is simply worth more than the market is acknowledging.
You heard it correctly - fully-diluted includes warrants issued but not exercised. Those would come into play at a buyout, previously exercised for cash or not. So in summary:
Market cap = O/S x current share price
Fully-diluted count = O/S + warrants
PPS at BO = BO price / fully-diluted count
It gets tricky when you’re trying to calculate certain values in real time because many investors will try to assess the value per share of a company like this on a fully-diluted basis, etc, when making their own investment decisions. This in turn may affect the actual PPS at a given point in time, since that’s simply a function of what people are willing to agree to sell/pay for a share at the moment.
Hope that’s helpful. Don’t mean to be patronizing in any way, just trying to clear it up as much as possible.
Most would calculate it as outstanding shares x share price. For example, E*TRADE currently has the market cap at $114.5mm, which at a share price of $0.57, puts the outstanding shares at around 200mm. I don't think any of the major platforms/brokers/outlets are using a fully-diluted count times the current share price to calculate a market value - that's a better method for trying to determine share price at a buyout.
So short story is that nobody has recently calculated us near a $200mm market cap!
No, you were “attacked”, as you put it, for redundantly posting the same thing over and over. (See what I did there?)
I think that you’re also likely not giving proper consideration to the difficulties inherent in partnering or licensing for one indication of a compound that has several major indications for the exact same compound. Can you imagine licensing ibuprofen for fever, but not headaches? To be fair, I don’t think that many people here are appropriately considering that difficulty.
We just got damn near every bit of information we could have dreamed of yesterday, short of notes of all internal meetings for the last 12 months. Everything looked great. Not good, great. They’re turning down money on bad terms and openly hinting that Pestell and his connections open doors to significant resources. Give it a rest and let management do what they’re doing. They’re not on this board listening to you anyways.
Interesting question for sure. I’d also like to hear input from anyone with significant experience in this realm. How would it be impacted by having parents for several and varied indications? And how would marketing protections under ODD for GvHD impact the protection for HIV? I would have liked to hear some talk about that on the call, but it probably wasn’t the most pressing issue when we hadn’t heard from management in nine months... Maybe on the next call, if we can’t get it well sorted before then.
Good question, WB.
So yes, they’ve been discussing it with the FDA all along and appear to have met the standards the FDA laid out. However, towards the end of he call some asked very pointedly about whether the investigational P3 for mono would be converted to pivotal or if a new trial would be required. I thought it was a good and necessary question, because I don’t feel it had been clearly addressed to that point. Pourhassan was very direct at that point about saying that they don’t know yet, and will not know until their next planned meeting with the FDA.
I can look at my notes and cite them in a little while. However, I agree with you that conversion is likely. It’s just not certain, as Pourhassan made very clear.
I largely agree. Couple that with the comments about turning down funding that was on less palatable terms, and the comments about how Pestell and his company should open the door to significant resources... and I can only surmise that they’re in solid talks for better funding of some sort. A solid partnership would be just fine by me.
No problem. Bulldog88 and inoviorulez both added useful context here as well. While I tend to side with their line of thinking, it is somewhat speculative as to what the FDA may require and I’ll refrain from guessing the direction it goes. What we definitely know is that we won’t know until that FDA meeting.
My hope is clearly that the data, particularly with the 700mg dose, will be strong enough for the FDA to see conversion as the best option.
Late in the Q&A session it was clarified that they would be having a meeting with the FDA once they had some data on the 700mg dosage in mono patients. That meeting will determine conversion to pivotal vs. whole new trial. It was very unclear early in the call.
Oddly, you sounded exactly as I always suspected you did. Great questions! The bit he snuck in about potentially not enrolling the entire GvHD trial was big. To me, he avoided talking about GvHD at all costs. I believe they actually think the FDA may stop the trial... but you don’t say that after the “golden quarter” fiasco.
Nice to hear a few voices I knew on the call, and it’s clear that there were several members of our community speaking who I just can’t put to an alias. Thanks to all who asked good questions.
Tommyterrific - there were a few Tom’s in there. I’ll assume you were one of them. Most likely the Tom who asked about the board and management shakeup.
My pleasure. There are plenty of others here who are doing great work as well - I appreciate all of the folks who routinely contribute their analysis.
Well, the article that is now live references a successful investigational P3 for mono, so...
I haven’t heard that from the company yet. Have you?
That’s a sanctioned leak. Buckle up for 4pm. I’m calling R/S announced today, highly positive mono update tomorrow.
I’ll treat your lack of punctuation charitably and assume that you weren’t calling me an idiot.
I expect you to be extremely vocal on the conference call this afternoon. You know, when people who can actually impact the situation are present and ostensibly listening.
That’s fantastic that you’ve solved the issue, and I appreciate each of the 14 times you’ve alerted the message board to your preferred path forward.
I think that if you post this just one more time on a message board, it’ll probably come true.
Still waiting for an explanation on this one, Saltz. All sounds good... but where did this come from?
Mike Sheikh is a contributor to Seeking Alpha. Aside from that, I have the same question as you, A17...
Appreciate the response. Looking forward to hearing what comes of the call tomorrow, and hoping that we can finally get this show started for real.
One day, I'm going to frame a bunch of technical analysis and simply tell anyone who asks about it that they're Jackson Pollock's that I picked up at a yard sale...
In all seriousness, I know that there's a lot of information there even if it looks like paint splatters to me. In plain English, it sounds like you're saying that the chart shows significant resistance at $0.50, correct? Any other big takeaways?
I think we actually agree. If the conference call goes great and it pops up to $0.75, someone putting $1mm in and expecting an eventual SP of $25 is going to be happier knowing that they had more complete information when they made the investment, and not care too much about the marginal return they could have made by jumping in today. There might be some timeliness needed to make a large investment here, but 24 hours isn't going to make or break it. Big fish will wait for that communication because they're smart enough to know that the 24 hours won't make or break the investment opportunity.
I'm definitely happy to see the movement on today's PR, and I wish the selling algorithms would let us get past $0.50, but I'm not too worried. The data appears fantastic to my untrained eye, and a larger price movement seems to be in order.
In reality though, no big money would jump in today, and they're not jumping in tomorrow either. If I had cash to invest and the PR this morning caught my eye, the first thing I'd have noticed in additional due diligence is that they have a nonbinding LOI for an acquisition out there and that they're holding a conference call - for the first time in nine months! - tomorrow afternoon. I wouldn't be putting in a dime until Wednesday morning when I've heard what management has to say.
That's the trading day I'm looking forward to... Wednesday. Let's see management knock it out of the park tomorrow at the conference call, and then look for investments coming in on Wednesday. I expect, based on the incessant whining here recently, that a number of people on this board will be putting the screws to management in the Q&A.
Nice to see some green today though. Nice to see some green.
Appreciate the response. What if the FDA were to - as I suspect they may - conditionally approve the GvHD indication on the strength of the P2 data, perhaps even the interim data? Would a conditional approval still be grounds for an sBLA?
This is an interesting topic, and one I definitely had not thought about. I’m not too familiar with this process - would you mind expanding on it? To me, it sounds like if the company were to get approval in one indication, it would reduce the burden and increase the speed with which they could potentially get additional indications approved. Is that correct? Would it also apply if the first approval were conditional approval? Say, if they conditionally approved it for GvHD after the next IDMC review...
I actually agree here. I think HIV is pretty much in the bag, it just needs time to finish up. Nothing in the data to suggest otherwise. GvHD close behind based on the amended protocol, and it may actually hit the finish line first. In the meantime, they’re expanding the repertoire while bringing in a top notch frontman.
I see nothing bad here. Looking forward to the conference call on Tuesday.
It may not. I sort of expect that it won’t, right away. But the fact remains that Pestell is the real deal. He’s everything we could want in a CMO, and should open doors in the industry and regarding fundraising. Should be very positive long term, in my humble opinion.
Good point, and let’s not forget the recently amended GvHD trial. The only assumption one can make is that they were observing significant efficacy there.
You’re not a basher, and some of the recent comments directed towards you have been very rude and incredibly uncalled for. However, when you post the same rant several times a day for a week or so - on deaf ears, no less... who do you think is listening? - it becomes irritating, to be charitable.
There are plenty of folks here who feel that management has done an admirable job in getting this far with the resources they’ve had, and it’s not incongruous to think that that same management team could have done certain things differently or may not be the BEST team for the job going forward. Many of these same people have positions that are large compared to their total portfolios, and most have been here a good while as well. Repeating yourself on your points about management is simply unhelpful.
Contact the board of directors. I guarantee that you can find them on LinkedIn. They can do far more than anyone on this board, if in fact there’s anything to be done.
And again, some of the comments recently have been very inappropriate. I’m sorry you’ve been subjected to that, because it’s unkind and unfair. This board is generally better than that.