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Post by babaoriley on Sept 14, 2018 15:32:25 GMT -5
I got the impression that Ray was lazy and ineffective. Other than that, he's a good guy.  |
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Post by tomtabb on Sept 16, 2018 21:06:59 GMT -5
The Agreement stipulates that MannKind will receive the $45 million upfront payment within 10 days of the effective date of the Agreement, which will occur after an antitrust review mandated by the Hart-Scott-Rodino Antitrust Act.
Once all parties to a transaction submit completed filings and pay the filing fee, there is a 30 day waiting period before the transaction may be completed. The government has the option of extending the waiting period by making a formal request for additional information if the transaction appears to them to present anticompetitive concerns, but the waiting period may also be terminated prior to the end of the 30 days if the parties request early termination at the time of filing and if the government elects in its discretion to do so.
I believe that the additional $10 upfront payment for R&D related to the development of another API has already been paid to MannKind. I nearly went blind reading the FTC Hart rodino stuff. I'm still amazed at how complicated it appears. Do you know whether Liquidia potential generic manufacturers can file any sort of complaint or protest as part of the process? Thanks. |
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Post by mike0475 on Sept 25, 2018 8:06:35 GMT -5
"The effectiveness of the licensing and collaboration agreement is conditioned on expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act." Does this mean the money changes hands in about 30 days and there are some filing prerequisites ? Curious in this timeline as well. Anyone know? |
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Post by mango on Sept 25, 2018 8:15:03 GMT -5
When is day 30 suppose to be?
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Post by xanet on Sept 25, 2018 8:20:14 GMT -5
"The effectiveness of the licensing and collaboration agreement is conditioned on expiration or termination of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act." Does this mean the money changes hands in about 30 days and there are some filing prerequisites ? Curious in this timeline as well. Anyone know? After both parties file paperwork (we won't know when that is done) there is a 30-day window during which additional information may be requested which will extend the timeline (we also would not know if that happened, but I would not expect it). After 30 days, assuming no extension of time, there are 10 days for the money to change hands. Either party may request early termination of the 30-day review, which may or may not be granted. We won't know anything until an announcement is made. |
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Post by Clement on Sept 25, 2018 8:23:15 GMT -5
FTC review ends 30 days from Sept 3 right? .... so, Oct 3 or 4, just after Cantor Fitzgerald on Oct 2.
But, the FTC could approve the deal early. I suppose money could then change hands and Mike could declare the deal concluded when he speaks at Cantor Fitzgerald. Just hoping!
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Post by xanet on Sept 25, 2018 8:55:44 GMT -5
FTC review ends 30 days from Sept 3 right? .... so, Oct 3 or 4, just after Cantor Fitzgerald on Oct 2. But, the FTC could approve the deal early. I suppose money could then change hands and Mike could declare the deal concluded when he speaks at Cantor Fitzgerald. Just hoping! The review is by FTC and DOJ. Do you know that both of these agencies had received the required paperwork and fees from MNKD and UTHR by Sep 3? The clock starts the day after. |
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Post by peppy on Oct 2, 2018 19:26:32 GMT -5
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Post by tomtabb on Oct 3, 2018 10:52:42 GMT -5
FTC review ends 30 days from Sept 3 right? .... so, Oct 3 or 4, just after Cantor Fitzgerald on Oct 2. But, the FTC could approve the deal early. I suppose money could then change hands and Mike could declare the deal concluded when he speaks at Cantor Fitzgerald. Just hoping! The FTC review ends when the FTC wants to end it; there isn't any deadline. It took them 3 months after the announcement of the Steadymed acquisition to approve it. |
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Post by mnholdem on Oct 3, 2018 11:38:38 GMT -5
I believe that can happen only if the FTC sends a letter within 30 days, such as requests for more information. If MannKind and UTC don’t get a letter, the deal is approved. I posted the regulations a few years ago when the Sanofi-MannKind deal was under review. Anybody should be able to look it up, though.
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Post by tomtabb on Oct 3, 2018 18:14:28 GMT -5
"During the preliminary review, the parties must wait 30 days (15 days in the case of a cash tender or bankruptcy transaction) before closing their deal. Based on what the agency finds, it can: 1) terminate the waiting period and allow the parties to consummate their transaction (this action often is referred to as an “early termination”); 2) let the waiting period to expire, which allows the parties to consummate the transaction; or 3) if the initial review has raised competition issues, the agency may extend the review and ask the parties to turn over more information so it can take a closer look at how the transaction will affect competition (this action often is referred to as a “second request.”"
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Post by sayhey24 on Oct 3, 2018 18:58:26 GMT -5
Here is what Mike said yesterday on the FTC - "So Treprostinil was partnered with the United Therapeutics, we expect FTC clearance in the coming week or two, but everything seems to be on track with that, so nothing going on there."
If Mike was truthful and I have no reason to think he was not, the approval is coming very soon, days away.
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Post by stevil on Oct 5, 2018 9:18:12 GMT -5
Am on my critical care rotation and am working closely with the pulmonologist. She wanted to know how TreT compares to the IV PAH meds. Has anyone seen any data on that?
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Post by tomtabb on Oct 5, 2018 20:15:55 GMT -5
Am on my critical care rotation and am working closely with the pulmonologist. She wanted to know how TreT compares to the IV PAH meds. Has anyone seen any data on that? In the Cantor presentation, there was only one slide showing tre-t results which appear to show that tre-t serum concentratios closely parallels tyvaso. That being the case, there are several reviews available -- e.g. link.springer.com/article/10.1007/s40262-016-0409-0. They all come down to similar conclusions: "When deciding between formulations, clinicians should individualize therapy selection based on the patient’s clinical status, health literacy, quality of life, co-morbidities, and any route-specific considerations. Table 1 highlights many of the risks and benefits clinicians may consider when choosing between formulations." Clinicians seem to prefer the pumps since they maintain a steady state, but it wasn't clear to me whether the pumps improved mortality/morbidity relative to inhaled. Somewhat off-topic, but interesting and perhaps relevant to afrezza as well: www.phacanada.ca/en/news-and-events/newsfeed/accessibility-of-pah-therapies-in-canada-part-ii/"Ultimately, both inhaled and oral treprostinil are not available to Canadian PH patients because the pharmaceutical manufacturer never submitted an application for Health Canada approval. This is largely because of business reasons, as the PH market in Canada is much smaller than in the US, and it is expensive to launch a new medication in Canada. Moreover, many PH medications cost less in Canada than in the US, because of government regulations. As such, the cheaper price for a new PH medication in Canada can lead to pressure on a company to reduce the price in the US, which would mean they make less money in the much bigger American market." |
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