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It does not matter what you say about the CRL. It matters what ELTP has been able to achieve in the past few years and has been developing in their pipeline.
"With Sequest being rejected and ......... Of course, its very likely Sequest never gets approved"
What do you see?
Expressing opinions is not the same as telling facts. Just like it's not a fact that FDA rejected SequestOx.
The more I read from your post, the more understanding I gain about T-max differences. Thanks again your valuable contribution here.
It seems that your concern of investing in a company rests mainly and more in its market cap & share price, than anything like strategic planning, corporate developments, product pipeline, leadership and management quality, etc.
Line managers sure are the chips being deployed by the master minds.
Just wonder why you always let clowns rather than smart people come to your meetings.
Haha .... I know. Don't worry.
As expected.
Glad to learn things are moving forward, despite some delay.
Thanks for the update.
WRONG!
NH: Is Elite still on target to submit two additional and as stated in the past CC? Yes, Elite is on target to submit two additional applications as stated in the other CC. It’s NDAs or ANDAs; it’s going to be definitely applications. It could be an ANDA or NDA. The most likely next two findings will be ANDA applications and they will happen this year.
http://seekingalpha.com/article/3983163-elite-pharmaceuticals-eltp-ceo-nasrat-hakim-q4-2016-results-earnings-call-transcript?part=single
Practices of FDA. In case you missed the information, here is just one of them to refresh your memory:
Why is FDA adopting the use of complete response letters?
A complete response letter provides a more consistent and neutral mechanism to convey that our initial review of an application is complete and we cannot approve the application in its present form. It provides a more consistent approach to informing applicants of changes that must be made before an application can be approved, with no implication regarding the ultimate approvability of the application. The adoption of complete response letters is one of the Agency’s commitments under the Prescription Drug User Fee Act (PDUFA).
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084143.htm
CRLs under § 314.110 were designed to "describe all of the specific deficiencies that the agency has identified".
Applicants receiving a CRL have 12 months to respond to the FDA in one of three ways under § 314.110(b)(1)-(3):
1. Responding to the CRL by resubmitting- The applicant can resubmit the application in its entirety, addressing each of the deficiencies described by the FDA in the CRL, using the suggested methods offered by the FDA in the CRL, or by applying the applicant's own solutions. The significance of the changes to the application will grant the FDA from 2 to 6 months of additional application review time.
2. Withdrawal- The applicant can withdraw the NDA or ANDA in its entirety. Note that such a withdrawal is without prejudice and allows the applicant to refile an application.
3. Request an Opportunity for a Hearing- The applicant can request the opportunity to meet with the FDA to discuss whether there are grounds for denying the application under § 505(d) and (j). However, applicants should be warned that these hearings are open and public hearings, and granting the hearing does not bind the FDA to actually reconsider the application.
These responses allow an applicant to respond to a CRL for the purpose of addressing the issues the FDA raised and which could, if left unaddressed, be the basis for a rejection of the application.
Quoted per post of Yub Duberson
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124272357
CRLs under § 314.110 were designed to "describe all of the specific deficiencies that the agency has identified".
Applicants receiving a CRL have 12 months to respond to the FDA in one of three ways under § 314.110(b)(1)-(3):
1. Responding to the CRL by resubmitting- The applicant can resubmit the application in its entirety, addressing each of the deficiencies described by the FDA in the CRL, using the suggested methods offered by the FDA in the CRL, or by applying the applicant's own solutions. The significance of the changes to the application will grant the FDA from 2 to 6 months of additional application review time.
2. Withdrawal- The applicant can withdraw the NDA or ANDA in its entirety. Note that such a withdrawal is without prejudice and allows the applicant to refile an application.
3. Request an Opportunity for a Hearing- The applicant can request the opportunity to meet with the FDA to discuss whether there are grounds for denying the application under § 505(d) and (j). However, applicants should be warned that these hearings are open and public hearings, and granting the hearing does not bind the FDA to actually reconsider the application.
These responses allow an applicant to respond to a CRL for the purpose of addressing the issues the FDA raised and which could, if left unaddressed, be the basis for a rejection of the application.
Quoted per post of Yub Duberson
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124272357
I am pretty sure the FDA also said "Sequests ADF was NOT 100% SAFE" too.
"Since product labeling with a specific food recommendation cannot fully mitigate this risk"
Thus the FDA has to let applicant know how FULLY practical for applicant to comply with a product labeling without a specific food recommendation that could FULLY mitigate the risk.
CRLs under § 314.110 were designed to "describe all of the specific deficiencies that the agency has identified".
Applicants receiving a CRL have 12 months to respond to the FDA in one of three ways under § 314.110(b)(1)-(3):
1. Responding to the CRL by resubmitting- The applicant can resubmit the application in its entirety, addressing each of the deficiencies described by the FDA in the CRL, using the suggested methods offered by the FDA in the CRL, or by applying the applicant's own solutions. The significance of the changes to the application will grant the FDA from 2 to 6 months of additional application review time.
2. Withdrawal- The applicant can withdraw the NDA or ANDA in its entirety. Note that such a withdrawal is without prejudice and allows the applicant to refile an application.
3. Request an Opportunity for a Hearing- The applicant can request the opportunity to meet with the FDA to discuss whether there are grounds for denying the application under § 505(d) and (j). However, applicants should be warned that these hearings are open and public hearings, and granting the hearing does not bind the FDA to actually reconsider the application.
These responses allow an applicant to respond to a CRL for the purpose of addressing the issues the FDA raised and which could, if left unaddressed, be the basis for a rejection of the application.
Quoted per post of Yub Duberson
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124272357
Practices of FDA. In case you missed the information, here is just one of them to refresh your memory:
Why is FDA adopting the use of complete response letters?
A complete response letter provides a more consistent and neutral mechanism to convey that our initial review of an application is complete and we cannot approve the application in its present form. It provides a more consistent approach to informing applicants of changes that must be made before an application can be approved, with no implication regarding the ultimate approvability of the application. The adoption of complete response letters is one of the Agency’s commitments under the Prescription Drug User Fee Act (PDUFA).
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084143.htm
Practices of FDA. In case you missed the information, here is just one of them to refresh your memory:
Why is FDA adopting the use of complete response letters?
A complete response letter provides a more consistent and neutral mechanism to convey that our initial review of an application is complete and we cannot approve the application in its present form. It provides a more consistent approach to informing applicants of changes that must be made before an application can be approved, with no implication regarding the ultimate approvability of the application. The adoption of complete response letters is one of the Agency’s commitments under the Prescription Drug User Fee Act (PDUFA).
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084143.htm
It's pretty funny to have discussed this issue the whole afternoon without any intention to seek clarification from ELTP. Come on, just an email will get the answer.
My understanding is different from yours. Only some of the NDA was not approved and thus required for resubmission. If an application is rejected, there wouldn't be such thing as
resubmission.
Practices of FDA. In case you missed the information, here is just one of them to refresh your memory:
Why is FDA adopting the use of complete response letters?
A complete response letter provides a more consistent and neutral mechanism to convey that our initial review of an application is complete and we cannot approve the application in its present form. It provides a more consistent approach to informing applicants of changes that must be made before an application can be approved, with no implication regarding the ultimate approvability of the application. The adoption of complete response letters is one of the Agency’s commitments under the Prescription Drug User Fee Act (PDUFA).
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084143.htm
This's record as of July 16, 2015. Any update?
This is just a highly valuable assessment for us to understand better the current situation ELTP with the FDA, from a medical professional's perspective.
Thanks WeeZuhl.
Why is FDA adopting the use of complete response letters?
A complete response letter provides a more consistent and neutral mechanism to convey that our initial review of an application is complete and we cannot approve the application in its present form. It provides a more consistent approach to informing applicants of changes that must be made before an application can be approved, with no implication regarding the ultimate approvability of the application. The adoption of complete response letters is one of the Agency’s commitments under the Prescription Drug User Fee Act (PDUFA).
In case you did not see this before.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084143.htm
In my opinion, below ten is highly unlikely.
Scared Trader, very precise conclusion.
Is the content of the following label difficult for users to understand for relief of acute pain when taking a pain killer?
DO NOT TAKE this drug if
1) not taken one before a meal or two hours after.
2) with a meal not sprinkled SequestOx during consumption.
3) taken more than 1 to 2 pills every 3 to 4 hours.
4) taken more than prescribed dosage.
I have got your PM. Thanks. As I am not a subscriber, so no more PM I can send. Appreciate your reply, sir!
Nevertheless, I can be reached at coo2002coo99@yahoo.com.
How about insert a label with the following:
DO NOT TAKE this drug if
1) not taken one before a meal or two hours after.
2) with a meal not sprinkled SequestOx during consumption.
3) taken more than 1 to 2 pills every 3 to 4 hours.
4) taken more than prescribed dosage.
I think August 10 CC will only give us progress report or highlights of the proposal to be provided to the FDA for feedback.
My question is if the issue could be resolved by changing label content, the NDA would have been approved leaving the label issue behind for further discussion and CRL would have been out of the way. So, I believe the concerns by FDA are not as simple as we think here unless the conspiracy theory about BP being behind the scenes is taken into account.
I agree it is not on a schedule. The label can also serve as a warning to prevent overdose within certain period of time.
1 hr before a meal or 2 hrs after a meal.
Add:
In any event, taking no more than x dose within y hours
Would that work?
That's FUNNY!
"Nasrat spoke what he chose to reveal. If it was true Nasrat disclosed the contents of the CRL on the CC, then whats the risk of disclosing the document itself, even a redacted version?"
Are you telling us none of what was disclosed by the CEO during the CC was no part of the CRL?
Maybe you can read the transcript on July 18 before determining if the CRL has been kept confidential.
BTW, I appreciate if you can elaborate how the CRL has been kept confidential while the contents of which were disclosed by the CEO during the CC.
Transcript of Conference Call held on July 18, 2016 is out now. Let's go through it for more better understanding of the CC.
About your repeated plausible statement that the CRL will never be made public by ELTP. Despite the fact that you have been told quite a few time here, may I remind you once again the following:
Complete Response letters are not made public by the FDA, and the text of the contents are not usually made public by their recipients either. The fact that a letter has been issued is announced, and corporate spokespersons are free to reveal what they wish about the contents of the letters to investors.
Maybe you should ask the FDA why they do not make it compulsory for recipients to reveal the contents of CRL to the public. I'm sure there must be some valid reasons to support that. Don't you think so?
vanwes1, is this the link and data that you have been asking for?
If so, please go read and dig into the details. Hopefully, we can hear something from you soon to get your rational analysis. Thank you.