|
|
Post by sweedee79 on Oct 20, 2021 13:05:58 GMT -5
If the FDA closed it out, then that opens the door for Lassman to seek judicial intervention which then turns things into a big mess which could delay the approval. My guess is based on FDA questions UTHR had a heads up this was an issue which allowed them to plan to bring this function in house and to start preparing a new submission. I would also think UTHR provided Mike a heads-up which allowed him to pull the trigger on the additional financing with the lease-buy back. At the same time we now know what the label looks like which allowed UTHR to pull the trigger on the 10 year manufacturing deal. While the CRL is a delay, IMO its about the best CRL I have seen. Back in the day we had Al Mann trying to get human insulin approved and without forcing the Adcom it may never have gotten approved. So wait a minute, you're saying that a group of people wanted to sabotage Tyvaso DPI from getting approved by creating an issue at a lab where Trepostinil is analyzed and filed a CP knowing that if Tyvaso DPI was approved or if the FDA closed out the CP then they could take further action by filing a lawsuit to delay the approval of Tyvaso DPI? That just can't be possible, that would neve happen in real life only in a movie...  LOL.. that's not what I got out of it... How I understood it is that the FDA couldn't close it due to legal repercussions... Due to the questions the FDA was asking UTHR they realized it was an issue , therefore that's why Mike pulled the trigger on the lease back.. I personally believe this CP was a bigger issue than the OPEN lab inspection.. |
|
|
|
Post by Thundersnow on Oct 20, 2021 13:58:34 GMT -5
I believe it was an excuse as well Harry... I'm right there with you.. and my thots about lqda's hand in this....
I know some will disagree.. but I just think it's odd.. because this is exactly what lqda wanted.... Not to mention that Martine paid a lot of money to get this expedited... Something just isn't right... LQDA would get the Treprostinil from UTHR as well. Wouldn't the Treprostinil supplied to them be the same tainted Treprostinil? What am I missing? Is this over my head? UTHR 12 month market advantage just got cut down to 3 months. DPI will launch in July and LQDA will be approved in October. UTHR wasted $105M and this DOGFIGHT continues. |
|
|
|
Post by mnkdfann on Oct 20, 2021 14:08:13 GMT -5
Words cannot express how happy I am that we can continue this discussion and CRL speculations until Summer 2022. |
|
|
|
Post by figglebird on Oct 20, 2021 14:08:52 GMT -5
how lqda will be approved in 3 months when they are filing against a nebulizer that is no longer a stand alone via pathway(505 b2) -apparently if a company has performed and filed studies of a investigational treatment that the FDA has overseen and guided the 505 pathway is no longer an appropriate fit - AND that's not even considering their results
|
|
|
|
Post by celo on Oct 20, 2021 14:42:38 GMT -5
LQDA would get the Treprostinil from UTHR as well. Wouldn't the Treprostinil supplied to them be the same tainted Treprostinil? What am I missing? Is this over my head? UTHR 12 month market advantage just got cut down to 3 months. DPI will launch in July and LQDA will be approved in October. UTHR wasted $105M and this DOGFIGHT continues. Differences between united and Liquidia: 2021 Revenue from Liquidia's injectable about 1 million/month 2021 Revenue from United Tyvaso about 50 million/month. (Both taken from 2021 2Q 10-Q's It is a massive head start if that is 50 times the number of patients or 50 times the number of prescribing doctors. We know what that has meant for Mannkind who has had a better product with Afrezza but can't get their foot in the door. Think about the reach United has with sales people and advertising over Liquidia. Let ue not forget, Liquidia has to jump one last hurdle with their fight with United. United won't go easy. On top of that United will be approved for PAH and PH-ILD while Liquidia will be approved for only PAH |
|
|
|
Post by figglebird on Oct 20, 2021 15:12:38 GMT -5
Maybe I am missing something then - maybe I read something and misconstrued.
505 b2 means an improved upon med in an area where where there is no data... If published data in the same Investigational area, emerges regardless of prior acceptance of filing the FDA is under no obligation to inform or pull application, HOWEVER, according to guidelines if such data exists - 505 b2 is no longer applicable.
These are guidelines - yes not set in stone but guidance all the same published by FDA in 2019 re 505 b2;
|
|
|
|
Post by Thundersnow on Oct 20, 2021 16:09:22 GMT -5
UTHR 12 month market advantage just got cut down to 3 months. DPI will launch in July and LQDA will be approved in October. UTHR wasted $105M and this DOGFIGHT continues. Differences between united and Liquidia: 2021 Revenue from Liquidia's injectable about 1 million/month 2021 Revenue from United Tyvaso about 50 million/month. (Both taken from 2021 2Q 10-Q's It is a massive head start if that is 50 times the number of patients or 50 times the number of prescribing doctors. We know what that has meant for Mannkind who has had a better product with Afrezza but can't get their foot in the door. Think about the reach United has with sales people and advertising over Liquidia. Let ue not forget, Liquidia has to jump one last hurdle with their fight with United. United won't go easy. On top of that United will be approved for PAH and PH-ILD while Liquidia will be approved for only PAH That is all true but UTHR bought the PRV for a reason. And now that advantage is gone. UTHR will still dominate but the FDA (and maybe LQDA) made sure UTHR will not have a 12 month lead. |
|
|
|
Post by sweedee79 on Oct 20, 2021 21:00:16 GMT -5
Someone on ST is saying United could file a fdrr (formal dispute resolution request).. an appeal of sorts.. and we could see approval as early as March.. I'm not sure of the validity of this.. anyone know anything about this? stocktwits.com/masspd/message/393540794 |
|
