Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I’m not so certain that strategically this expansion should be at the completion stage as opposed to the planning stage. Sometimes you have to take chances in business. But hindsight is 20/20. There should still be plenty of opportunity out there down the road.
Gilead and Halo under the same manufacturing roof makes one curious. Gilead’s CEO said they were exploring subcutaneous administration on Face the Nation. He did not mention how they were doing that. Halo offers potential subcutaneous administration through its Enhanze platform.
Could there be more to the expansion plans than what is known publicly? I can guarantee you this with all the govt. dollars going toward Remdesivir, which currently is administered by IV, makes one wonder. Exploration of subcutaneous administration will likely be given the highest priority and not be made public until and unless it passes FDA review. Halo’s Enhanze and Gilead’s Remdesivir — just my opinion but it is all very curious.
According to this article: https://bioprocessintl.com/bioprocess-insider/facilities-capacity/avid-buoyant-despite-top-client-halozymes-restructure/
“We’ve obviously had significant discussions with Halozyme. As we understand it, we won’t have any negative impact for the discontinuation of one of their products,” Avid’s CEO Rick Hancock said on his firm’s recent Q2 call.
“Halozyme, as they have stated, will be very, very focused on their Enhanze platform and the materials that we produce here at Avid supports that Enhanze platform. So, no negative impact can be anticipated there” he said.
The information in this article is what I would like to hear more about. What prompted this article? Any Californians with access?
Ziebell was legal council for PPHM. He is legal council for CDMO. He is the common denominator. His expertise is focused in fiduciary duties for BOD’s. Look no further than that to know why communication has not changed. He is an obvious believer of give them only what is necessitated legally. I don’t personally agree with that approach. It shows little confidence and it brings more discontent and mistrust by those who have financed the company. But it’s not wise to ignore the guidance of your legal representative as business leaders. And a lack of transparency does not prove anything nefarious concerning their intent. I guarantee you they believe they have communicated what they need to legally. Ziebell is no rookie in this regard. And I also guarantee all shareholder communication goes through Ziebell not Stephanie as some seem to insinuate. She does the tough job of simply following their lead.
The question we all have concerning intent will be answered. Without any definitive proof of illegal action I objectively choose to trust. Successful businesses rarely follow a straight line upward to success. Believe me that I know definitively. And it wasn’t long ago where there were no complaints because we were moving much higher. I refuse to give in to an emotional response. I believe we will be fine. But there are obviously no guarantees. If you look at the situation objectively we are in a good situation!
I guess I have to presume that you are talking about me having connections to the inside since I received the reply. That’s a stretch. That reply was received after I made them aware that we are quite knowledgeable on the rules of material information — as my reply to Stephanie’s pad worthless reply that everyone has received. It surprised me as much as anyone to receive a real answer. And I made it known that all shareholders deserve such information. Now I am one to trust until I’m given reason not to. I appreciate the answer and believe it should have been made public. I have no connections inside the organization.
The past is not the present. In my opinion, this group has not done well on the communication front. They have had some hiccups in their pursuit of success — as every successful business has. But they are not the previous group. I believe that sincerely. They still have to prove their capability but to compare them to our previous so called leadership is just being handcuffed to the past. I understand it. I fight it too. But I have come to the conclusion that they have given me, personally, no reason to not trust in their intent. To let go of the past and view this through a current and realistic lens is each persons choice. Personally I see a successful future for this company and I hope they have the courage to change their communication tactics with shareholders. To date I see nothing that compares in any way to the previous group. And I am thankful to have this second chance at success. I am letting go of the past to the best of my ability. I believe it’s the healthy approach for me. Everyone must make their own choice.
For what it’s worth this did not come from Stephanie. This communique came directly from Compton. I just don’t see the new guy with a stellar track record deceiving shareholders. What does he gain from that? I trust what he says until he gives me reason not to.
All of Avid's development, manufacturing, and quality operations are continuing as scheduled without interruption and in compliance with local, state, and federal guidance.
Not vague to me. Pretty straight forward that all manufacturing is up and running. Nothing vague about it — to me.
Everyone has their own interpretation. And that’s fine. Good luck to us all.
No. They are up and running. Business as normal. It doesn’t appear they had any major issues getting the problem fixed and having the machine back up in operation. This is the response I received when inquiring and there is something similar on the site in the red covid-19 update box.
All of Avid's development, manufacturing, and quality operations are continuing as scheduled without interruption and in compliance with local, state, and federal guidance.
We are inspired by the dedication and perseverance of our talented employees who continue to come to work during these challenging times. Avid employees whose job duties do not require them to be physically on site are working from home to promote social distancing. Please visit our website for additional updates as they become available
There are 2 business development people employed at this time.
The answer concerning the fix of the problem that I received from Stephanie on March 12th 2 days after the quarterly call. That is into the final quarter 2020 that ends April 30th. So they were still down at the time of the call which was into the 4th quarter already. Hopefully up by now.
Bob,
As Rick stated, the problem has been diagnosed and we are, “now implementing the necessary corrections...” Repairs are underway.
Stephanie
Lawyers were needed for the previous management group. Steve King and the remaining BOD were milking shareholders. They were screaming for legal action in my opinion. We also did not trust the transfer of the IP because the other BOD was involved along with a questionable brokerage firm and pursued transparency. I’m not an advocate for legal action with companies that perform well but at times deal with adversity. That is a different issue.
This group just received stellar marks essentially from their customer base. The lack of communication is frustrating but not a crime in my opinion unless they are withholding material information. We usually hear status updates during the quarterly calls. I’m sure they are consulting with their legal department about each situation that arises.
I’m not a frivolous pursuer of lawsuits. I certainly want them to be truthful. I mainly want them to perform. I want to see new customers and high efficiencies. I want to see progress as I’m sure every shareholders wants. And I want to see them sell at a healthy premium. Nothing else.
Sent you a screenshot to your email
I saw it when I went to the site from my phone. I have a screen shot if you want me to send it?
That type of notoriety certainly can be leveraged by the business development team. Excellent work by the entire team at Avid.
They also have put out a communication on their website concerning continuing operations uninterrupted. We thank them for that.
Outside of announcing new contracts this is excellent news. More new contracts will come.
From Stephanie: Avid’s critical operations remain in operation as our business is within the critical infrastructure sectors as essential business. We will continue to monitor the situation to make sure that we are compliant with all local and statewide directives.
Avid has 200+ employees. The definition of small business for government funding grants is less than 500 employees. As soon as our illustrious lawmakers pass an emergency funding bill Avid can take advantage. Hopefully that happens today!
And of course there is the matter of financing this. The government needs to get this low interest loan program going and cut the red tape. It is likely an opportune time to get needed financing cheaply and easily without having to jump through bureaucratic hoops. They can take advantage of this to the extent prudent.
Again this is an opportunity to show they are taking a winning approach to a challenging time. This is a time for them to shine.
Of course this is assuming they are down. I don’t think anyone really knows. Maybe they are okay to continue with necessary employees because they do work in an aseptic environment. We should be updated soon.
I hope they are taking advantage of this downtime with a skeleton crew of necessary employees working strategically to keep contact to a minimum. It’s an aseptic environment during production so it’s as clean as it can get! It’s safer than being at home. No virus can live in that environment. And they have all the means to keep it clean and work clean. It’s part of the normal culture during operation.
Are they taking care of critical maintenance items and updates to the operation? Are they ensuring the chosen personnel that they are critical to the operation and cannot be fined? And if a situation arises they will cover any fines ensuring chosen employees they have their backs. Have they created a hit list of critical items and are they knocking them out during this challenging time? This is a window of opportunity to focus on critical items!
Are they success minded and working strategically? Likely. This is an opportunity. Richieri knows his stuff. I’m sure he’s taking care of business.
So that, theoretically, should help Avid’s supply chain which is a positive. I’m trying to understand if it goes farther than that? Will it also boost demand for biologics manufacturing here in the US? Not clear to me on that front.
I worked 30 years in the manufacturing field for a couple of fortune 100 companies and I know very well that shipt happens. And it happens all the time. The fact that there were no regulatory issues and they did not lose the business indicates the problem was handled properly. Now I can’t speak to whether it was handled efficiently. That’s an unknown.
It’s unfortunate but it does not surprise me. Machines can be fickle things. It sounds like they should recover well by the first quarter next fiscal year. Sometimes mishaps happen regardless how well a process may be managed.
I do agree that they need to be more transparent.
Hope so. Wait mode for CDMO.
It was said that the trial must be a registrational trial. None of the trials to date, to my knowledge, are registrational trials.
From a reliable source. “There needs to be substantial positive data for the FDA to approve the initiation of a Phase 3 registration trial. So the phase 1/2 in HCC and this trial in gastric which each combine with pembro are designed to develop the data required to convince the FDA to allow a phase 3 registration trial.”
This individual also said it could take years before the FDA is provided the data necessary to rule on a registrational trial.
We do know that trials need to be registered or, I believe, confirmatory before any potential milestone payout can occur. Seems all they are doing is exploratory studies at this point. Such studies can take years according to a reliable source. It’s tough to get excited about any milestone prospects. But I’m sure we don’t see the whole picture.
From an expert that is knowledgeable on these trials.
“this is a Phase 2 study. it is not randomized and cannot be a registrational trial -
there needs to be substantial positive data for the FDA to approve the initiation of a Phase 3 registration trial. So the phase 1/2 in HCC and this trial in gastric which each combine with pembro are designed to develop the data required to convince the FDA to allow a phase 3 registration trial.”
Makes sense that milestones are not paid until they get into a registrational trial assuming the data warrants the next move into such a trial.
?
Thank you.
As a follow up:
“The Guidelines acknowledge that combination products can satisfy the inventive step standard, at least when a synergistic effect can be demonstrated. In fact, there are good policy rationales supporting the availability of patent protection for inventive combination products, particularly, but not exclusively, when the combination results in a synergistic effect. Patents provide an incentive for innovators to discover combination products that provide improved therapeutic outcome compared to either individual active ingredient. Perhaps even more significantly, patents (along with test data protection) provide an incentive to fund the expensive human clinical trials necessary to verify and validate the clinical benefits.”
https://www.liebertpub.com/doi/full/10.1089/blr.2018.29073.cmh
Yes with Merck involved I’m sure there is strategy we aren’t privy to. They wouldn’t waste their time on a drug that was losing protection shortly after any potential approval. Marketing exclusivity can be used as a potential strategy. There are a number of ways to extend protection.
https://www.ajmc.com/journals/supplement/2016/how-drug-life-cycle-management-patent-strategies-may-impact-formulary-management/a636-article
It’s not so cut and dry. This is what I found:
The 20-year patent protection clock starts ticking when and if the patent is granted (~ within 2 years or so?), even though the product will NOT be to market for another 6-8 years!!! The Hatch-Waxman act can 'give back' some of that time by extending the patent for 1/2 of the years the drug was under development and testing.
https://www.biology.iupui.edu/biocourses/Biol540/4pipeline09Full.html
It’s the first post here. Still haven’t found it anywhere else.
https://finance.yahoo.com/quote/CDMO/community/
It came off another board. It lists as a post from 10 days ago. No date and no source. I’m trying to validate. I haven’t seen this before. But it sounds fairly recent if it in fact is accurate. If not someone went to a lot of trouble to make it sound legit. I can’t see why it wouldn’t be.
https://www.google.com/amp/s/www.sitejabber.com/reviews/zacks.com/amp
Zacks reviews are far from stellar. I wouldn’t put much faith in their ratings. Nothing has changed with CDMO IMO. It’s still a company that should thrive IMO.
That’s exactly why we need clarity.
I guess there should be no milestones then. It’s all a charade. Who put this contract together again? Was it the old group? They set the milestones? Or was it the new group just trying to appease? I’m not fully following your logic. But I do get your point that it is all a charade. Thanks
Well I think you met your goal. Didn’t you?
I hear your opinion and respect it. The company has no legal obligation to share anything that is not material. The milestones only become material when met. But knowing the history of this company it would be prudent for company officials to be sensitive to stockholders desires. Why not? It is good practice to be transparent, especially concerning issues that many stockholders see as potentially important. I mean a mere mention of Bavi milestones on the Avid site with a link to Oncologies site would likely go a long way in satisfying some curiosity. But they seem intent on sweeping this under the rug and that creates mistrust. It’s important that we don’t allow them to do so. What else aren’t they sharing? That is the issue. It’s important we let them know our concerns.
You don’t seem to get it corp. This is not about getting rich. Its not about any illusions of grandeur. It’s about ensuring company officials are being forthright with information that can have an affect on your investments bottom line. Or we can all just stick our heads in the sand and hope for the best. If you are a true investor you should be at least curious as to how close we may or may not be to any milestone being met. Why are they so illusive with such information. Or you can keep eating sand. It’s your choice.