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The point is CRL's can be issued for NDA's and ANDA's and Elite has several ANDA approvals with no CRL's. How about that?
And how many CRL's for the ANDA's Elite has already submitted...several of which have already been approved BTW?
A company needs to submit ndas to get crl. Here is the track record for elite 1 nda =1 crl lol
Okay, is there a link where any pharma has provided the original copy of a CRL that they received?
What a load of BS. Nasrat hid nothing about the SequestOx Tmax issue. When Elite met with the FDA in 2014 they indicated the issue could be remedied with labeling instructions.
https://s3.amazonaws.com/sec.irpass.cc/2258/0001144204-16-113802.pdf
"The result of the BE study for SequestOx as comparing SequestOx to the brand were bioequivalent for the area under the curve, Cmax and Tmax. Comparing the profile of SequestOx under fasted versus fed conditions indicated that a fatty meal slows down the Tmax, not the Cmax or AUC but the Tmax. Historically this has been a labeling issue whereby the product is labeled and the doctor and the pharmacist will instruct the patients to take the product an hour before a meal or two hours after a meal.
"In our meeting with the FDA in November of 2014, Dr. Hertz requested three extra studies:an efficacy study (a Bunionectomy), an anti-abuse study and a BE study - sorry, it was a withdrawal study and a BE study. We indicated that we know that there is a food effect on our product so why are we doing another BE study for fed? FDA clearly stated that this is not a pass or fail, it’s a BE for labeling issue."
So, all of the requested tests (by Dr. Hertz) were completed and the NDA was filed. Then, having received the application, the FDA changed their mind and decided labeling could not be used and issued a CRL. Doesn't seem fair but it's a fact of life when dealing with the FDA and their habit of providing guidance then changing their mind.
I believe you know why if it's the alcohol dump test you are referring to.
why did it get the CRL in the first place ??????????????
There were no negative incidents during the SequestOx PIII trial. BTW all trial participants were permitted to eat whatever they wanted; i.e. fatty or low/non-fat meals. I believe that is what Chasing is saying.
Well, of course, SequestOx has zero casualties since the FDA has declined to approve it and allow it to get in the hands of patients.
Transcript for August 12, 2019 Conference Call:
https://seekingalpha.com/article/4284978-elite-pharmaceuticals-inc-eltp-ceo-nasrat-hakim-q1-2020-results-earnings-call-transcript?part=single
What. . .less than a million in cash now? I must be reading the last Q all wrong.
They have less than a million in cash on hand now (maybe $600K).
Actually the nonsense is denying there was a shortage of Adderall IR and its generics. This shortage, which occurred earlier this year, is well documented.
elite had nothing to do with a non existent shortage
Yes, but there is a missing message from the board thread alleging Nasrat was not able to "forcast" the Q1 rev's. Glad I could clear up this hilarious nonsense.
Nah. . .the nonsensical allegation was that Nasrat was not able to "forecast" the Q1 results which, of course, is BS.
The Q1 rev's will double from approx. 1.4 mil to 2.8 mil as indicated in the last CC and the soon to be released financials. I am not sure how the PPS will react to this doubling event but it is laughable nonsense to suggest Nasrat did not know during the CC (on June 24) what the Q1 rev results would be a week before Q1 ended. Yes, Nasrat was confident in declaring Q1 rev's because he knew how much was on the books.
Absolutely. . .1.4 to 2.8 mil in Q1 rev's. I agree. . .that is stupendous. Yippee!!!
Yep. . .still looking forward to that 1.4 to 2.8 mil double in rev's. It's already in the books. Yippee!!!
Absolutely. . .a double from 1.4 to 2.8 mil. Looking forward to it. Yippee!!!
Yep. . .Q1 rev's in books. . .1.4 mil to 2.8 mil. I agree; case closed.
Hysterically funny. The revenue statement was made when Q1 was two weeks from completion. I would think Elite would have known by then how much revenue was on the books when the guidance was given. So yes the revenue will double and not the laughable nonsense alleging it will decrease.
Yes and it is still disingenuous and nonsense to state that "earnings" (revenues) will decrease this coming quarter when revenues will be doubling.
Yes you are right. I was responding to the bullshit about "lower earnings".
And yes, it is revenues that the guidance is talking about. LMAO
Can't wait for another lower earnings than the previous 16 quarters.
Well. . .that's a load of bullshit. The 2019 Q4 earnings were approx. 1.4 mil. Guidance provided during the last CC indicated the earnings for 2020 Q1 would be double or approx. 2.8 mil. LMAO
Can't wait for another lower earnings than the previous 16 quarters. Wonder if it will hold the .03's this time???
The Q1's for the previous three years were filed on August 9 and, if the trend continues, this coming Q1 will be filed next week on Friday, August 9. The CC will probably occur on the following Monday.
no link = BS
Sungen is a privately owned company but I was told it trades overseas. Should be easy to look up their financials which are posted over
there. . .right? LMAO
n2k. . .yes, I had a good laugh when I read that. It was pure unsubstantiated crapola. GLTY
To say Elite will fail and Nasrat will come out with a nice retirement is BS of the highest order and clearly absent knowledge about preferred shares
I am willing to wait for the approval of ANDA #2 and subsequent appreciation in share price. I would love to revisit this thread when that happens.
Sorry, but what is conjectural is any hope for ELTP when the market clearly is telling us that there is little or no hope for the last desperate gasp..( SunGen )
Sorry. . .but that is more conjectural nonsense.
So when Nasrat's J series shares are converted to common stock and the Elite ship sinks (hypothetically). Wouldn't his shares go down with him like the rest of the shareholders? Nasrat is the largest shareholder in Elite (he owns 20+%). He has the most to lose should something happen to Elite. Please tell me how he would benefit from a disastrous event when the rest of the shareholders are drowning.
As i said before, he will float away from the sinking on a very cushy featherbed that he has constructed for himself while others drown.
More nonsense. I am not buying it. ANDA #1 approved/launched with ANDA #2 on deck for approval in December. And yes, the next CC will shed more light on Sungen/Elite alliance in a favorable manner. Let's wait and see shall we?
SunGen will be no different..another smoke screen that won't amount to a hill of beans.
Nah. . .that's bullshit
Conjectural nonsense. Elite/Sungen ANDA #1 was approved and launched in May with ANDA #2 scheduled for approval in December and now I am supposed to believe the deal with Sungen is invalidated? LMAO
The conversion of Series J shares to common stock is locked in at .1521 cents a share. Now if you are talking about stock dividends which are tied to the J's or the sale or grant of shares below the conversion price (shares not be part of the core number of J's) then yes there could be a deviation from the stated .1521 conversion price.
And your reference to the possible conversion of J's at .07 cents to result in 343,348,571 shares won't happen because, as I previously stated, the J's are locked in. Any related transactions to the issued core number of 24.0344 series J could involve a deviation of the conversion price such as (from the 10K - page 79):
"Subject to certain exceptions, the Conversion Price is subject to adjustment for any issuances or deemed issuances of common stock or
common stock equivalents at an effective price below the then Conversion Price. The Conversion price also is adjustable upon the happening of certain customary events such as stock dividends and splits, pro rata distributions and fundamental transactions."
https://s3.amazonaws.com/sec.irpass.cc/2258/0001213900-19-011224.pdf
Summary: There is no ratchets associated with the core Series J shares.
Newguy. . .I like your sense of humour. GLTY
Ha. . .good one. I agree, good news is a comin'
It’s called cover your butt and run.... Good news is coming lol
What a load of bullshit. LMAO
Thanks JJ. The approval of Adderall XR will be a milestone event for Elite in that it will be the largest potential revenue producing ANDA ever filed by Elite (and Sungen). I am anxiously awaiting this approval and launch. It will be a great day for all shareholders.
Spot on post. Elite/SunGen received approval of Adderall IR, just a matter of time for Adderall XR in my opinion.
I am pretty sure he will not "dance around it". If there is cause for delay he will say so in the CC. That's my opinion.
I strongly disagree with this misinformation. Fact is the CEO stated in the last CC he expected approval for the Sungen CNS product #2 in the calendar Q2 period (April - June). June is not over yet. Elite is awaiting approval from the FDA. There is nothing more Elite can do now other than wait.
Face it, this is now well over due. Something is up and the company is not being transparent. CEO will dance around the issue at upcoming CC
Newguy. . .interesting info. I did not know that.
Let's lay this to rest once and for all. It's BS to allege Sungen trades at all. It is a privately held company. . .no trading occurs on any exzchange.
Sungen trades over seas at $0.0001
Show me a public company does NOT have an "Investors" tab on their website.
Waiting. . .