Eugene_O
Posted - 1 month ago
$AMYT Fidelity just deposited the money from both CVRs just before market close. Waiting on Merrill.
Eugene_O
Posted - 1 month ago
$AMYT It looks like any bank holiday in either Dublin, London or New York does not count as a business day. Dublin has Feb 1st, London Dec 26th an New York has Feb 12th as extra days closed. So it seems the payout date will be February 20th.
Chrono_Z
Posted - 1 month ago
$AMYT Have they shared any details on CVR payout following approval?
kuda8
Posted - 2 months ago
$AMYT Thanks , bad news for STS101 Satsuma .
Eugene_O
Posted - 2 months ago
$AMYT Found the answer. Payments will be made for the Milestone 1 CVR based on the approval. Milestone 2 is also met. Congrats everyone. https://chiesirarediseases.com/media/fda-approval-for-filsuvez-topical-gel
Eugene_O
Posted - 2 months ago
$AMYT So does this apply? § 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. Approval under this section will be subject to the requirement that the applicant study the drug further, to verify and describe its clinical benefit, where there is uncertainty as to the relation of the surrogate endpoint to clinical benefit, or of the observed clinical benefit to ultimate outcome. Postmarketing studies would usually be studies already underway.
Eugene_O
Posted - 2 months ago
$AMYT It looks like the approval for DEB includes the Recessive type required for Milestone 1 and was granted under Priority Review but not Accelerated Approval, and so seems that the conditions were met. "DEB usually presents itself at birth and is divided into two major types depending on the inheritance pattern: recessive dystrophic epidermolysis bullosa (RDEB) and dominant dystrophic epidermolysis bullosa (DDEB)."
Eugene_O
Posted - 2 months ago
$AMYT Does the approval for dystrophic epidermolysis bullosa include the recessive type? “Milestone 1” means an approval issued by the FDA for Filsuvez, with any such approval to include a labelled indication related to wound healing in patients with recessive dystrophic epidermolysis bullosa (or a broader indication)"
Eugene_O
Posted - 2 months ago
$AMYT
Eugene_O
Posted - 2 months ago
$AMYT does not appear on the "Accelerated Approval" list.
Eugene_O
Posted - 2 months ago
$AMYT Filsuvez was designated "Priority Review".
kuda8
Posted - 2 months ago
$AMYT “Milestone 1” means an approval issued by the FDA for Filsuvez, with any such approval to include a labelled indication related to wound healing in patients with recessive dystrophic epidermolysis bullosa (or a broader indication) at any time on or akter the date of the Transaction Agreement or prior to the relevant Milestone Deadline Date; provided that such approval is not granted by the FDA under 21 C.F.R. §§ 314.510 of FDA’s regulations (i.e., accelerated approval). It seems FDA granted under 21 CFR , will ask their Lawyer Dechert in charge of the deal .
Eugene_O
Posted - 2 months ago
$AMYT Looking good for both these CVRs. How many CVR holders on here? "CVRs of up to US $2.50 per ADS are payable if certain milestones related to Amryt’s product Filsuvez® are achieved before December 31, 2024, consisting of US$1.00 per ADS upon FDA approval of Filsuvez® and US$1.50 per ADS upon successful receipt of a Priority Review Voucher from the FDA."
Eugene_O
Posted - 2 months ago
$AMYT Both CVRs are valid it appears.
kuda8
Posted - 3 months ago
$AMYT Chiesi got FDA aproval for Filsuvez , good for the first CVR ?
STCKPRO
Posted - 4 months ago
$AMYT NEW ARTICLE : Poolbeg Pharma beefs up leadership; brings key players from succesful Amryt Pharma team https://www.stck.pro/news/AMYT/66947184/
TrendyChart
Posted - 5 months ago
Upcoming Earnings Report: $AMYT Amryt Pharma will be reporting on 11/06/2023 at 7:00AM | Are you expecting earnings to be above or below expectations?
TrendyChart
Posted - 5 months ago
Upcoming Earnings Report: $AMYT Amryt Pharma will be reporting on 11/02/2023 at 7:00AM | Are you bullish or bearish on earnings for this stock?
StillnessofBreath
Posted - 10 months ago
$AKBA I was just reading $AMYT filed FDRR around us or even later than us. They got acquired without the result out!
tickeron
Posted - 10 months ago
Amryt Pharma plc to report earnings on May 03, 2023. Earnings per share (EPS) estimate: $-0.01 $AMYT https://srnk.us/go/4621556
Nostradamus696
Posted - 11 months ago
$TRIL $AMYT $CINC $HZNP have had great fortune being a part of the some of the best biotech acquisitions of all time. Altimmune is next!!
Quantisnow
Posted - 11 months ago
$AMYT New live insights:
1. 📜 SEC Form EFFECT filed by Amryt Pharma plc
https://quantisnow.com/i/4370098?utm_source=stocktwits
2. 📜 SEC Form 15F-12B filed by Amryt Pharma plc
https://quantisnow.com/i/4370103?utm_source=stocktwits
3. 📜 SEC Form EFFECT filed by Amryt Pharma plc
https://quantisnow.com/i/4370106?utm_source=stocktwits
#healthcare
stockilluminati
Posted - 11 months ago
$AMYT https://www.stockilluminati.com/amyt/filings.php - Amryt Pharma plc - American Depositary Shares files form EFFECT today, check out the details.
Quantisnow
Posted - 11 months ago
$AMYT 📜 SEC Form EFFECT filed by Amryt Pharma plc
https://quantisnow.com/i/4370097?utm_source=stocktwits
45 seconds delayed.
fla
Posted - 11 months ago
$AMYT [15s. delayed] filed form 15F-12B on April 24, 06:00:57 https://s.flashalert.me/U97LNK
fla
Posted - 11 months ago
$AMYT [15s. delayed] filed form EFFECT on April 24, 00:15:20 https://s.flashalert.me/EaSZI
fla
Posted - 11 months ago
$AMYT [15s. delayed] filed form EFFECT on April 24, 00:15:24 https://s.flashalert.me/S9bgb
fla
Posted - 11 months ago
$AMYT [15s. delayed] filed form EFFECT on April 24, 00:15:11 https://s.flashalert.me/xOujUj