Seems like history is going to repeat itself again with FENC. After not getting approval and crashing down, FENC is slowly making its way back to the $6.00-6.50 area. IT will probably stay there until we start to hear good news on the next attempt to get approval and as we approach the approval deadline I see us being back around $9.00 - 9.50. That is all I can almost guarantee. Hopefully, they get the approval so it skyrockets to $14-15. Just a waiting game.
b
I don't care if it takes 1-2 years for approval if this gets in the $3 range I am loading up. It proved to get up to $10 right before approval and an average price forecast of $15 after approval. This company is only Pedmark so it needs to get approval. The whole focus for the next year will be on this issue. Once resolved an investment at this current entry will give you a 100% return preapproval and 275% from approval. I think it is worth an investment after we find the bottom. What do you think?
L
Another CRL for manufacturing issues. This could delay approval 6-9 months. Fennec will definitely need to raise more cash through stock sale or debt.
K
Patience! 50% down is not appropriate reaction. Check the volume is only 3 million. No institution are selling. We should to review the new response letter before posting negative about the management. This is an opportunity for an entry, Institution ownership increased from 45% to 50%.
D
Why is the PDUFA target date Nov 27th on a Saturday ? Doesn't seem to make sense. I'm guessing if it falls on a weekend it won't happen until the following week.
R
Suspicious day today with heavier than usual trading and downward stock pressure. Is there already insider knowledge about the FDA decision?
J
Many researchers explored the effects of FDA drug authorizations on stock prices. A recent study using 344 FDA events revealed a significant wealth effect of 1.56% following a positive FDA announcement. This study also found that financial market losses from product development failures are much larger than financial market gains from product development successes; indicating an asymmetry in the response of financial markets (Sharma and Lacey 2004). A more recent event study demonstrated stock prices showing significant abnormal returns following a final FDA decision (Sarkar and de Jong 2006).
Analysis of Stock Market Reactions to FDA and EMEA Announcements
Author: Joachim De Schrijcer
Z
Seems like a buy today!
S
Does anyone have a time frame on the European Medicines Agency's decision? When was the MAA submitted? And how long does the review normally take?
B
Fennec management is not trustworthy; they skimp on production in facilities that will never meet approval…
Fool me once, shame on you. Fool me 10 times, shame on me. If a business comes down to its leadership, shareholders should consider forcing a change in fennec’s ‘leadership’.
S
FDA did it again. Pulled "..manufacturing deficiencies.." out of its box of cheap excuses. If they found deficiencies during inspection they would have issued 483s.
J
14 days and counting
Food and Drug Administration (FDA) has accepted for filing the resubmission of its New Drug Application (NDA) for PEDMARKTM (a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors. The Prescription Drug User Fee Act(PDUFA) target action date has been set for November 27, 2021. “We are pleased that the FDA has accepted our PEDMARKTM resubmission,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals, Inc. “We look forward to working closely with the FDA through the review process. We are committed to bringing this treatment to children receiving cisplatin chemotherapy, an area of high unmet medical need. If approved, PEDMARKTM stands to be the first FDA approved therapy to reduce the risk of cisplatin induced ototoxicity in pediatric patients.”
j
Pdufa coming up and fenc has been steadily going up. If the nes is good fenc could quickly drop so be careful.
be careful and quick! smaller companies are not known and FDA approval can make prices go down due to hedges selling off and not much retail activity. if there is no squeeze then the price will drop
C
Nothing but disgusted
s
(ARDS) MC 31 m ..2x HUGE Phase 3 Drugs =2000% UPSIDEE
I
This thing is real? 11% down?
c
FDA doesn't want this to be approved. So maybe big pharma could scoop this up at 2/share. Such BS.
F
There are people here promoting erroneous information about just how long a time frame will be involved in getting the manufacturing issues fixed, and it's not going to be a matter of weeks or even just a few months as some are saying! Here's the accurate regulatory guidance from the FDA, and note that FENC will have to submit a "Class 2 Resubmission," which once received can take as long as SIX MONTHS for FDA action: https://www.fda.gov/media/84417/download. Note that among the factors that will require a Class 2 resubmission are "2. A new manufacturing facility(ies) or would warrant a follow-up assessment and/or inspection of manufacturing facility(ies);... ." See page 3, paragraph D. 2.
https://libstore.ugent.be/fulltxt/RUG01/002/062/116/RUG01-002062116_2013_0001_AC.pdf
Analysis of Stock Market Reactions to FDA and EMEA Announcements
Author:
Joachim De Schrijcer
Fool me once, shame on you. Fool me 10 times, shame on me. If a business comes down to its leadership, shareholders should consider forcing a change in fennec’s ‘leadership’.
Food and Drug Administration (FDA) has accepted for filing the resubmission of its New Drug Application (NDA) for PEDMARKTM (a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors. The Prescription Drug User Fee Act(PDUFA) target action date has been set for November 27, 2021.
“We are pleased that the FDA has accepted our PEDMARKTM resubmission,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals, Inc. “We look forward to working closely with the FDA through the review process. We are committed to bringing this treatment to children receiving cisplatin chemotherapy, an area of high unmet medical need. If approved, PEDMARKTM stands to be the first FDA approved therapy to reduce the risk of cisplatin induced ototoxicity in pediatric patients.”