Tips for a successful NDA submission
Marketing application submissions, including NDAs, BLAs, and PMAs in the US, are the culmination of years of research and the final hurdle before a product makes it to market. This complimentary webinar will share tips on regulatory strategy, data integration and readiness, and electronic publishing that can help you avoid common pitfalls in the submissions process.
Reserve Your Spot Today! Horst, better sign up immediately. Oh I forgot he got smart and is partnering the entire pipeline to companies that know how to develop, submit and commercialize the IGXT pipeline. Kudos on both accounts. Absolutely the right thing to do, other than sell the company NOW!
Real you sound like your talking about yourself spewing insults, hopes and dreams for over 2 years now and the PPS has gone from $1.18 to the .50's in that time and you are one proud dumb ss. Yes, I have been a proponent of experienced business management and finally it has happened. Difference been you and I is you have never done any D&D just regurgitate what Horst says, make up fairly tale statements and attack anyone with a different opinion. The truth means nothing to you. You are a legend in your own sick mind. You definitely need help. Do yourself a favor and anyone around you and get it.Yes, I may be older than you, but you are an old man
"having manufacturing capability and a broader management team has lead to a much higher level and intensity to their deal-making capability from what I have heard."
That I agree on ad have stated many times over the last year or more as prior deals didn't turn out. The Dava and Par deals are several years old and when Dava was bought out they returned the drug as Par did 2 out of 3. The new deals are very important and with the expanded management guys in only a couple of months got two deals going in that time. Hopefully we will see several more n the coming months. There is the rest of the EU for migraine, Migraine in the U.S.,Cialis worldwide and several others in the pipeline that need to move forward and will faster with development/commercialization partners.
As far as 450 I believe they did get a $1M on the extension of the agreement, but that is only $5M in milestones since Dec. 2012 and they haven't made that much in royalty revenue less costs since 10/2012 when it was approved (4 years ago).
The positive is it looks like they are now moving the pipeline along at a much faster and with the new management and new development partners shouldn't see anymore CRL's. Its the new guys and partners that will make this company valuable. Horst has done all he can do business wise. He wants to and needs to retire and only consult from the board. Kudos to him for getting the company in the position it is in now to add value and stop the stagnation and inefficiencies (CRL's).
Patrick that is why these two new deals are so important to complete as the only development/commercialization deal they have completed was the Par deal for 3 drugs and 2 were given back, which should be good news because now they can get a better deal than the one with Par. 450 was just a commercialization deal and that is not a great deal for IGXT even though it is doing well. Out of the $23M in milestones they have only received $4M to date.
There is some validity to what you say, but Horst has been fairly frugal in the past other than the issuance of now 74M shares, none sense 21/2 years ago. Hopefully the development agreements bringing in upfront payments for now is his strategy to cover the short fall in the cash flow, along with lowering IGXT's R&D expenses by passing them on to the new partners. Upfront payments and lower R&D costs will also add to ForFivo income to hopefully offset any losses until new revenues come in in mid to late 2017.
Drug Manufacturers Accused Of Engaging In Product-Hopping | Jere ...
www.jerebeasleyreport.com › Fraud › Drug Manufacturer Fraud Litigation
Mar 14, 2016 - Reckitt Benckiser, Inc. Suboxone Film versus tablet. Interesting article. May be a positive in regards to current lawsuit.
The very first interview with Horst, Horst interrupted the new CEO and you could see he never intended to give up any control and that is why the CEO was sent on his way. I am sure as I have seen many times before in business the founding owner has a very difficult time bringing in a high level executives to run their business. I will add I did not think he was a good choice, but at that point who wanted the job and Horst wouldn't have worked with anyone.
Nice pump, but Singular didn't say that at all. Wainwright has a 12 month price target of $2. Depending on the deal they strike for the 3 drugs and Riz in the EU, filing ED and refilling Riz in U.S., then I believe that is very is very realistic within 12 months. If they continue to execute development/commercialization deals for the rest of the pipeline that number could increase. I also think that in 2018 that number will rise with income starting to ramp up.
Short term with reasonable upfront milestones for the two deals being executed this quarter with another major pharma the PPS will exceed singular's .80 target PPS. Both Singular and Wainwright seem to be convinced that IGXT will earn the $15M milestone this year one in 3rd Qtr. the other thinks by year end.
Both think the current valuation I cheap considering the value of the pipeline and neither included any dollars or value to the two deals that aren't executed yet.
2nd the LOL. I was here the last split when we thought we had Pfizer, but now just a drug in early development with maybe some interest. PPS went down before the split and up after the split back then from $4.80 to about $7.
This time it will go down before and after, unless the announce a development partnership or sell the drug or rumor that something is happening.
Health Canada inspection went well, there be other inspections throughout the rest of the year as they get machinery installed and do test strips. Per Edward
Morning Star report has IGXT as undervalued with a quantitative value of $.87 or at $.52 = 40% undervalued.
Price/Quant Fair Value 0.87
Price/Earnings 29.1 — 26.6 20.7
Forward P/E 11.9
Once term sheets are executed the PPS should exceed $.87, with two film filings by year end it could be over $1, that's a possible double within 7 months or less.
Volume is your name , but at these low volumes no market maker can make enough money to give a #$%$. How about nobody cares. They need the deals and some filings along with a lot of PR to get the volume up where any one cares.
I was thinking film strips for over the counter drugs as an alternative for boosting sales of products with the new and faster delivery of those products. Just a thought since Horst brought up cough and cold medicine.