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Thanks. I didn't consider that could be the reason.
If that is the case, is it likely that the FDA will not find out? I know there is the site inspection. I'm not sure if they would expect Joshi to be present for that, for example.
Rightly or wrongly, my initial reaction upon seeing this hidden away in the proxy material was to question management integrity. I assume management would be aware of investor perception, so they must feel it is important.
I agree, Joshi has likely not been involved for quite some time. Sjuts may be qualified in terms of marketing and sales, but I don't see him as qualified for resubmitting the BLA, running operations, or ensuring the facilities are up to standards for the FDA inspection.
It is difficult to make an evaluation when the scientific/production side is unknown.
As a side note: announcing items of significance, such as the departure of your COO, in the footnotes is concerning.
It is concerning that they have not named a replacement as of yet.
I am also surprised there is no announcement of his departure as they did with Rankin. Dr. Joshi's exit from the company was hidden in the footnotes.
Is this perhaps a signal that Revance will be without a COO for some time?
It seems I was wrong. From the most recent release:
Dr. Joshi will transition from the Company and cease serving as our Chief Operating Officer and President, R&D and Product Operations effective March 31, 2022. Dr. Joshi is expected to continue to provide consulting services to the Company in a non-executive officer capacity until June 2023.
Aubrey Rankin has also left the board.
They very quietly announced his departure.
Who is in charge of manufacturing?
Yes, I think we are in general agreement. Perhaps some minor differences on the level of Joshi's involvement, but at the end of the day that likely matters little. If Revance is seeking outside help, I think it is in the best interest of shareholders. Hopefully the next conference call will give us some colour.
I think it would be difficult to bring a new hire up to speed, and I am not confident another employee would have the knowledge and experience to fix the manufacturing issue or take over in any real capacity for Joshi.
I think you're right that they hired a contract worker to advise on the manufacturing issue and to ensure a smooth re-application process, but I believe Joshi is still in charge of manufacturing overall. I think this would make for a smoother process and would avoid any potential delays or mistakes that might occur if somebody new or an underling were to take over in anything more than an advisory role.
If the goal is for a speedy re-application, this would likely be the best option for the company.
Wasn't your contention that Joshi was no longer a reporting executive officer? This form 4 would indicate that he is, would it not? Or am I mistaken as this is for grants from 2020?
Given that isn't it more likely that he is still in charge of manufacturing but has been demoted from the number two position and perhaps agreed to or had his new grants forfeited for a period due to the failed inspection?
I do not see who else would be able to take charge of manufacturing and preparations for Daxi approval at this point.
It appears Abhay Joshi is among the most recent form 4 filings. As the shares were vested subject to his continuous service, perhaps it was simply a clerical oversight.
Haha, that guess was perhaps more of a hope of mine.
I will give it one more attempt if that is allowed. For point vi, the words "regulatory and product" were inserted after clinical timings. Perhaps an indication they believe the sBLA for cervical dystonia could be approved this year, pending approval of the BLA for Daxi?
I am not too familiar with the sBLA process admittedly so I may be way off base.
Could it be the change from cash capital expenditures to cash runway, which may be indicative that they believe that they will not require a raise in capital? Though I find this unlikely to be a clerical error. I would also expect them to require to raise cash, but cash runway is a strange change from capital expenditure budget.
iv) could indicate that they believe Daxi will receive approval in 2022, though I would hazard as guess that this bonus would partly be for re-submission, so I wouldn't put weight behind this. This bonus seems to be in line with your estimate of re-submission and approval in late 2022, early 2023, perhaps with a bonus if the product is approved in 2022.
Dew,
Regarding Daxi approval, Revance's states second half of 2021 for a verdict. Is this standard speak or do you think they are indicating approval may take longer than anticipated after inspection?
It's my understanding that in states such as Texas, the political risk is fairly low. Nor do I put much stock into the fear that politicians will make any drastic changes regarding oil production.
Fracking has its upsides and downsides, but the cost of production of several oil companies in the US is still lower than Canadian with the added benefit of quicker scaling up or down of production in response to oil prices.
With that said, I only hold MGY, as I am not interested in most oil and gas companies in the US or Canada. I would only invest in a low cost of production and low leverage oil company. I do not have as much confidence in the management of the majority of companies in an industry that is full of highly leveraged companies that are now being forced to deleverage.
Thanks. I believe this is similar to what I was thinking. Even if there is a discount for CD and upper-limb due to pending approval, I can't imagine waiting would be worth the (likely?) small premium. Particularly with the continued cash burn that this wait would involve.
I don't necessarily think there is a problem waiting until after CD and upper-limb, but my preference would be to sell beforehand - assuming they receive an acceptable offer. I don't see there being much gain in waiting.
Thanks for the responses, Dew. I've been following RVNC, and your posts for awhile now. It's always great hearing what you have to say.
In my opinion glabellar lines would be the main focus in any buyout scenario. Waiting would involve additional cash burn for the company. I'm not sure how much additional value you would get out of waiting.
I'm not necessarily against waiting, and am open to other opinions regarding CD and upper limb. I could very well be wrong. Does anyone else have an opinion on this?
Thanks for the response. That makes sense. The FDA approval process has taken longer than I think anyone could have anticipated. The additional cash burn has been an unfortunate consequence.
I appreciate the insight.
Considering the language used when Foley was announced as the newly appointed CEO, do you believe something has changed to make the company consider going their own way? I thought the language heavily implied they were open to or ultimately seeking a buyout when Foley was hired. Though these things are always open to interpretation.
I agree that $60 would be a relatively low offer if there is FDA approval and the label is good.
Thanks! That's what I thought, but I thought I'd ask since I've seen you mention selling RDS if your cost average wasn't so low a couple of times. I wasn't sure if you were perhaps just pessimistic on oil / oil companies in general.
Is there any benefit to Canadian oil over US? Breakeven in Karnes and I believe a few other areas in Texas is high 20's or low 30's. Return on investment for a well can be as few as 5 or 6 months at $50-60 a barrel. Of course the wells have a higher decline rate, but this can help a company adapt to different pricing climates.
Public sentiment / political sentiment seems to be against Canadian oil as well. Not to say there aren't any good Canadian oil companies, but all else being equal I don't have as much confidence in Canadian oil compared to several US companies.
Do you hold that opinion for all oil companies? I'm not much of a fan of Canadian oil or the oil majors, but I see some of the smaller US operations as potential buy and holds.
Disclaimer: I hold MGY which is operating in South Texas.